Search Results (466)

Breast implants are among the most frequently used long-term implantable medical devices in aesthetic and reconstructive surgery. In addition to correcting anatomical deficits, they have significant psychosocial effects, influencing body image, self-esteem, and quality of life, particularly in patients undergoing postmastectomy reconstruction. This review provides a comprehensive overview of the historical development, biological interactions, material characteristics, and clinical outcomes of breast implants. Early reconstructive attempts using foreign materials and injectable substances were associated with severe complications, underscoring the need for safer technologies. The introduction of silicone gel implants in the 1960s marked a pivotal advancement, followed by the development of saline-filled devices and highly cohesive silicone gels with enhanced mechanical stability. Key surgical considerations, including incision type and implant placement plane (subglandular, submuscular, dual-plane, and subfascial), are discussed in relation to aesthetic outcomes and complication risk. Emphasis is placed on the implant–tissue interface and the foreign body response (FBR), a process involving protein adsorption, immune cell activation, fibrous capsule formation, and potential chronic inflammation. Persistent inflammatory stimulation, often associated with bacterial biofilm formation, contributes to capsular contracture, the most common long-term complication. Additional adverse events include implant rupture, silicone gel bleed, granulomatous reactions, infection, hematoma, implant malposition, and rare but clinically significant conditions such as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The review also summarizes implant classification according to construction, filling material, shape, and surface topography, highlighting the influence of surface characteristics on host response and clinical outcomes. Advances in biomaterials, cohesive gel formulations, and surface engineering aim to enhance biocompatibility and long-term safety, supported by standardized mechanical and biological testing protocols. Full article

Immune checkpoint inhibitors (ICIs) have substantially improved outcomes in advanced melanoma but are frequently linked to immune-related adverse events (irAEs). Vitiligo is a common cutaneous irAE and has been consistently associated with improved patient outcome, including prolonged progression-free and overall survival. It also represents significant visual stigma, particularly when the face is involved. Traditional treatment comprises topical steroids, calcineurin inhibitors, laser, and phototherapy which often have insufficient effects. Since 2023, the first approved drug for non-segmental vitiligo (NSV) with facial involvement, the topical Janus kinase inhibitor ruxolitinib, has been available. However, experience with its use in ICI-induced vitiligo remains limited. In this exploratory analysis, three patients who developed facial vitiligo following ICI therapy applied 1.5% ruxolitinib cream to affected facial areas twice daily. After six (two patients), and twelve months (one patient), extensive repigmentation was observed, quantified at 95.7%, 78.9%, and 99.1% using a novel semi-automatic tool. Quality-of-life questionnaires showed mean reductions of 57.6% (Vitiligo DLQI) and 68.2% (Vitiligo-specific Quality of Life) in disease burden. Treatment was associated with substantial repigmentation without observed side effects. Further evaluation in larger, prospective cohorts is warranted to better define treatment effects, clinical applicability, and long-term safety. Full article

Background: Immunotherapy has become an integral part of systemic treatment for cervical cancer (CC). This study assessed the safety profile of cemiplimab and the association between immune-related adverse events (irAEs) and treatment outcomes in patients with persistent, recurrent or metastatic CC. Methods: This ambispective, multicenter, real-world cohort study included 101 patients treated in 13 reference oncology centers as part of the PCCIG-01 study. We evaluated the frequency and severity of irAEs and their association with progression-free survival (PFS) and overall survival (OS). Survival outcomes were analyzed using the Kaplan–Meier method and Cox proportional hazards models, with p < 0.05 considered statistically significant. Results: After a median follow-up of 7.5 months, adverse events occurred in 45 patients (44.6%) and were mostly grade (G) 1–2. IrAEs were observed in 34 patients (33.7%). Endocrine toxicities predominated (n = 24, 58.5% of irAEs), followed by hepatic (n = 5, 12.2%) and gastrointestinal events (n = 4, 9.8%). G3 irAEs occurred in 8 patients (7.9%). Median PFS was 3.9 months (95% CI 2.9–5.6) in patients without irAEs and 10.9 months (95% CI 5.7–16.3) in those with irAEs (p = 0.03). Median OS was 15.3 months (95% CI 8.6–25.9) in patients without irAEs and was not reached in those with irAEs (95% CI 11.6-NR; p = 0.11). The development of irAEs was associated with a 54% reduction in the risk of progression (HR 0.46, 95% CI 0.27–0.80), with no statistically significant impact on OS. Conclusions: In exploratory analyses, the occurrence of irAEs was associated with improved PFS in cemiplimab-treated patients with persistent, recurrent or metastatic CC. Cemiplimab showed a manageable safety profile, with most toxicities being G1–G2. Full article

Soft tissue sarcomas (STS) are locally invasive and aggressive tumors that occur spontaneously in humans, dogs, and cats. High-intensity focused ultrasound (HIFU) is a non-invasive ablation technology that has been explored in canine but not feline STS. The objective of this pilot study was to determine the in vivo safety and feasibility of HIFU ablation for feline STS and to investigate the impact of HIFU on the acute immunological response. Client-owned cats diagnosed with spontaneous STS were recruited. Computed tomography (CT) scans of the chest, abdomen, and tumor were performed prior to treatment for staging and treatment planning. A commercially available HIFU unit (Echopulse, Theraclion, Malakoff, France) was used to target portions of solid tumors before standard-of-care surgical resection. Ablation efficacy and local immunological response were characterized using histopathological and immunohistochemical assessments. Acute safety was monitored with physical examinations, owner reports, and CBC/serum biochemistry. Multiplex serum cytokine levels were used to evaluate the systemic immune response. A total of three cats diagnosed with STS were recruited and treated. No significant adverse events attributed to HIFU treatment were noted in this pilot study. In treated areas, hemorrhage as well as coagulative and lytic necrosis were observed microscopically and were more extensive than in untreated tissues. There was a statistically significant difference in the level of serum MCP-1 after HIFU treatment, but no significant changes in any other analytes. No differences in the infiltration of CD3-, CD79a-, or IBA1-positive cells were noted between treated and untreated samples. Overall, findings suggested that HIFU may offer a viable alternative to conventional therapies for feline STS, with pilot results showing effective tumor ablation in cats with STS without significant adverse events. Some preliminary evidence of immunomodulation following treatment was observed, but HIFU as an immunotherapeutic treatment option needs to be further investigated. Full article

Immunotherapy with immune checkpoint inhibitors (ICIs) has profoundly transformed the therapeutic landscape of lung cancer. Although ICIs are generally associated with a more favorable toxicity profile compared with traditional chemotherapy, rare and potentially severe immune-related adverse events (irAEs) may occur, sometimes posing significant diagnostic challenges. We report a case of macrophage activation syndrome (MAS) following a single administration of the anti-PD-L1 antibody atezolizumab in a patient with advanced non-small-cell lung cancer (NSCLC). A 62-year-old woman was diagnosed in February 2024 with stage IIIB NSCLC according to the 8th TNM classification. The patient was deemed ineligible for radiotherapy because of previous thoracic irradiation for breast cancer. First-line therapy with carboplatin plus pemetrexed was administered from March to June 2024, resulting in stable disease; this was followed by pemetrexed maintenance from July to October 2024, at which time thoracic disease progression was documented. Second-line treatment with atezolizumab was initiated in November 2024. Ten days after the first infusion, the patient was admitted to the emergency department for fever and confusion. Laboratory investigations revealed markedly elevated C-reactive protein and hyperferritinemia. Despite empirical antibiotic therapy, fever and thrombocytopenia persisted. Bone marrow biopsy demonstrated findings consistent with MAS. Corticosteroid therapy with prednisone at 1 mg/kg was promptly initiated under rheumatologic supervision, leading to a rapid clinical and biochemical improvement. During tapering, inflammatory markers relapsed when prednisone was reduced to below 12.5 mg/day. Given the occurrence of a grade 4 (CTCAE v5.0) immune-related adverse event, atezolizumab was permanently discontinued. The patient remains in follow-up without radiological evidence of disease progression. This case highlights the diagnostic challenge of MAS secondary to ICIs, which may initially present with nonspecific symptoms such as fever, confusion, and elevated inflammatory markers. Early recognition and timely initiation of high-dose corticosteroids were essential for effective management and full recovery. Clinicians should maintain a high index of suspicion for MAS among rare but severe hematologic irAEs during immunotherapy. Full article

Combined immune checkpoint inhibition (ICI) and multitargeted tyrosine kinase inhibition (TKI) improve outcomes in advanced melanoma, especially in heavily pretreated patients, but introduce complex, overlapping toxicities. Although immune-related adverse events and TKI-specific toxicities are well characterized individually, their concurrent presentation is uncommon and can obscure diagnosis. Capillary leak syndrome (CLS), a rare but potentially life-threatening complication of ICIs, further complicates recognition due to nonspecific features and variable onset. A 43-year-old woman with metastatic BRAF wild-type melanoma, in complete metabolic response on lenvatinib and pembrolizumab, presented with generalized edema, hypotension, thrombocytopenia, and marked erythroblastosis. Extensive evaluation, including bone marrow analysis, excluded malignancy, infection, and autoimmune disease, but revealed multilineage dysplasia with pronounced erythroid stress. Imaging confirmed sustained remission with pleural effusions and ascites. Dual toxicity was suspected: lenvatinib-related hematologic toxicity and pembrolizumab-associated CLS. Both agents were discontinued, and corticosteroids followed by IVIG for steroid-refractory edema led to gradual recovery. This case underscores the diagnostic challenge of overlapping ICI–TKI toxicities. Mechanistically, VEGF pathway inhibition may disrupt marrow endothelial integrity and hematopoietic homeostasis, promoting cytopenias and erythroid precursor release, while immune activation drives cytokine-mediated endothelial dysfunction and vascular hyperpermeability. Early recognition and prompt immunomodulatory management are critical to improving outcomes. Full article

Background: Although immune function and tumor biology follow circadian rhythms, it is unclear whether optimizing the timing of immunotherapy can enhance clinical outcomes. This study evaluated the association between time-of-day administration of immune checkpoint inhibitors (ICIs) and treatment efficacy, and explored whether blood type modifies ICI response in Chinese lung cancer patients living in an alpine region. Methods: We performed a retrospective analysis of 1247 Chinese lung cancer patients treated with first-line chemoimmunotherapy between January 2016 and March 2021 at Harbin Medical University Cancer Hospital (Cohort 1, n = 839) and the Fourth Affiliated Hospital of Harbin Medical University (Cohort 2, n = 408). Primary endpoints were overall survival (OS) and progression-free survival (PFS) estimated by the Kaplan–Meier method. Secondary endpoints included immune-related adverse events (irAEs), disease control rate (DCR), and objective response rate (ORR). Results: Patients treated before 13:00 had superior outcomes compared with those treated later, with longer mOS (34.3 vs. 22.0 months, p < 0.0001) and mPFS (16.7 vs. 12.7 months, p < 0.001). The ORR was significantly higher in the before 13:00 group of Cohort 1 (64.4% vs. 55%, p = 0.005). Additionally, blood type O was associated with a higher irAEs rate (35.6% vs. 20.1%, p < 0.01) and longer mOS (34.5 vs. 23.1 months, p < 0.0001) than non-O types. Conclusions: Time-of-day administration and blood type may influence ICI efficacy, supporting circadian-informed and patient-tailored immunotherapy. These findings support incorporating circadian timing and patient-specific factors into cancer immunotherapy strategies. Full article

Background: Guillain–Barré syndrome (GBS) is an autoimmune peripheral neuropathy that can lead to paralysis and respiratory failure. In addition to infections, several drugs have been suggested as potential triggers of GBS. This study investigated drug-associated GBS using a spontaneous adverse event reporting database through disproportionality analysis for signal detection and time-to-onset analysis. Methods: The Japanese Adverse Drug Event Report (JADER) database was analyzed to assess more than 4000 drugs for potential associations with GBS. Signal detection was performed using reporting odds ratios, Fisher’s exact test, and total report counts. For vaccines and immune checkpoint inhibitors, time-to-onset patterns were further evaluated using Weibull distribution analysis. Results: Disproportionality signals suggesting potential associations with GBS were identified for 45 drugs, including vaccines, immune checkpoint inhibitors, tumor necrosis factor-α inhibitors, other anticancer drugs, antifungal agents, and interferons. Reports following vaccination were most frequently observed within 1–3 weeks after administration of coronavirus disease 2019 (COVID-19), influenza, and pneumococcal vaccines, and within 1–3 months after human papillomavirus 2-valent vaccination, with a gradual decrease thereafter. Reports following immune checkpoint inhibitor use were most frequently observed 1–3 months after nivolumab, ipilimumab, and pembrolizumab administration, whereas atezolizumab showed a peak in reporting within 1–3 weeks. In contrast to vaccine-related reports, no clear temporal trend in reporting was observed. Conclusions: Drugs that modulate immune function, including vaccines and immune checkpoint inhibitors, may be associated with reported GBS events. Vaccine-related reports showed an early concentration in time to onset, whereas immune checkpoint inhibitor-related reports did not demonstrate a clear temporal pattern. These findings should be interpreted as hypothesis-generating and warrant further investigation. Full article

Background/Objectives: Nivolumab plus ipilimumab (IO–IO) provides durable clinical benefit in metastatic renal cell carcinoma (mRCC), yet long-term real-world data focusing on progression-free and treatment-free (PF–TF) survival remain limited. This study aimed to evaluate the long-term outcomes of IO–IO with a particular focus on the frequency and clinical characteristics of PF–TF. Methods: We retrospectively analyzed 63 patients with mRCC treated with first-line IO–IO across eight institutions with a minimum potential follow-up of five years. Progression-free survival (PFS), PFS2, and overall survival (OS) were assessed. PF–TF was defined as absence of disease progression and any cancer-directed therapy at the five-year landmark. Clinical and treatment-related factors were compared between patients with and without PF–TF. Results: The median PFS, PFS2, and OS were 7.5 (95% confidence interval [CI], 5.1–13.3), 26.2 (95% CI, 13.6–46.6), and 47.4 months (95% CI, 29.3–not reached), respectively. At 5 years, 11 patients (17%) achieved PF–TF. Baseline characteristics, IMDC risk classification, and peripheral blood biomarkers were not predictive of PF–TF. PF–TF was associated with the absence of bone metastases, presence of lymph node metastases, and occurrence of immune-related adverse events (irAEs), as well as the delayed onset of irAEs. No PF–TF patients required corticosteroid pulse therapy, and durable PF–TF was observed even after early treatment discontinuation due to adverse events. Conclusions: IO–IO demonstrated sustained long-term efficacy in real-world practice, with a subset achieving durable PF–TF. These findings highlight IO–IO as a strategy capable of providing long-term disease control with reduced treatment burden in selected patients with mRCC. Full article

Background/Objectives: Influenza remains a primary cause of severe illness and death in adults over 60. In this group, immunosenescence and existing health conditions make infections more dangerous and traditional vaccines less effective. The MF59-adjuvanted vaccine was specifically designed to overcome these limitations by enhancing the body’s immune activation and antigen presentation. While the vaccine shows clear benefits, some recent concerns regarding vaccine safety have been raised without supporting scientific evidence. Therefore, this systematic review focuses on providing a comprehensive evaluation of its safety outcomes compared to standard vaccines. Methods: Following the PRISMA guidelines, a systematic review and meta-analysis were conducted; two researchers independently assessed the eligibility of the studies, and the risk of bias was assessed using RoB2 and ROBINS tools for randomized clinical trials and observational studies, respectively. Pooled risk estimates were calculated using a random-effects model. Results: Ten RCTs and three non-RCTs meeting the inclusion criteria were included. No significant differences were found for severe systemic outcomes: Guillain–Barré syndrome (RR 1.01, 95% CI 0.64–1.80) and encephalitis (RR 1.23, 95% CI 0.85–1.78). For other systemic adverse effects, there were no significant differences between adjuvanted and non-adjuvanted vaccines; only myalgia showed a small but significant increase with adjuvanted vaccines (RR 1.35, 95% CI 1.02–1.78) compared with non-adjuvanted vaccines. Conclusions: MF59-adjuvanted influenza vaccines have a favorable and well-characterized safety profile in adults aged 60 years and older. Adverse events are predominantly mild and transient, with no evidence of increased risk of serious or immune-mediated outcomes compared with non-adjuvanted vaccines. Full article

Background/Objectives: Diffuse large B-cell lymphoma (DLBCL) is molecularly heterogeneous, and approximately 30-50% of patients fail to achieve cure with standard R-CHOP. Genotype-directed first-line therapy may improve outcomes by targeting subtype-specific oncogenic pathways. This study evaluated the feasibility, efficacy, and safety of a molecularly adapted R-CHOP-X strategy with two-year follow-up. Methods: In this single-center, prospective, non-randomized study conducted between September 2023 and the data cut-off (16 September 2025), 43 adults with newly diagnosed DLBCL (excluding high-grade B-cell lymphoma, primary immune-privileged, and primary mediastinal large B-cell lymphomas) underwent tumor genotyping using the LymphGen classification after targeted sequencing: a 19-gene Sanger panel (Cohort 1, n = 35) or an expanded 60-gene panel (Cohort 2, n = 8; proof-of-concept). All patients received one initial cycle of R-CHOP as bridge therapy pending molecular profiling results, followed by five cycles of R-CHOP-X, with the additional agent (vorinostat, acalabrutinib, decitabine, or lenalidomide) selected according to molecular subtype. Response was assessed by PET/CT per Lugano criteria; adverse events were graded per NCI CTCAE v5.0. Results: The overall study population was predominantly high-risk: 72% had an IPI of 3–5, 58% had stage III–IV disease, and 67% exhibited a non-GCB immunophenotype. Expansion from the 19-gene to the 60-gene panel reduced unclassifiable (NOS) cases from 34% to 12%. The overall response rate was 100% (43/43); complete response among patients completing therapy was 100% (35/35). At two years, overall survival was 92% (95% CI 83–100%) and progression-free survival was 94% (95% CI 86–100%). Two early relapses occurred (NOS and N1 subtypes), both resulting in death. Grade 3–4 neutropenia, thrombocytopenia, and anemia occurred in 26%, 12%, and 7% of patients, respectively; no dose reductions or treatment discontinuations were recorded. Conclusions: Molecularly adapted R-CHOP-X is feasible and associated with high response rates and favorable two-year survival in newly diagnosed DLBCL, comparing favorably with historical R-CHOP outcomes in high-risk populations. Expanded genomic panels substantially improve molecular classifiability. These findings warrant validation in larger, multicenter, randomized clinical trials. Full article

Background: Pneumococcal conjugate vaccines (PCVs) prevent severe disease in children, but high costs limit access. PCV10-SII (PNEUMOSIL), a 10-valent PCV prequalified by the World Health Organization (WHO) in 2019, offers a cost-effective alternative. This study assessed its safety and immunogenicity in Vietnamese children aged 6 weeks–24 months. Methods: An open-label, single-arm study enrolled 304 children in three age groups: 6 weeks–6 months (n = 151), >6–12 months (n = 76), and >12–24 months (n = 77). Participants received two or three doses. Safety was evaluated through immediate reactions, adverse events (AEs), serious adverse events (SAEs), and withdrawals. Immunogenicity was measured 28 days after the final dose using serotype-specific IgG geometric mean concentrations (GMCs), opsonophagocytic activity (OPA) titers, and seroresponse rates. The trial was approved by the IRB of the National Ethics Council (code: No. 75/CN-HĐĐĐ on date 4 June 2021) and was registered with ClinicalTrials.gov, NCT05140720. Results: Of 304 enrolled participants, 294 (96.7%) completed follow-up. No immediate adverse events or serious adverse events occurred. Unsolicited adverse events were reported in 17%, mainly respiratory, while serious adverse events occurred in 4%. Mild local/systemic reactions (e.g., injection site pain, crying) resolved without sequelae. Immunogenicity was strong, with GMCs 1.8–9.11 µg/mL, GMTs 277.8–22,342, and seroresponse rates >90% for 9 of 10 serotypes, serotype 6B demonstrated a slightly lower seroresponse rate of 88.6%. Conclusions: PCV10-SII demonstrated favorable safety and robust immunogenicity, supporting its inclusion in national immunization programs as an affordable option for pneumococcal disease prevention. Full article

Background: Liberia modernized vaccination data systems in 2023–2025 by piloting a District Health Information System (DHIS2)-based Digital Vaccination Registry (Electronic Immunization Registry, EIR) to address the limitations of paper-based workflows and of a proprietary COVID-19 electronic platform (offline gaps, lack of unique identifiers, performance issues and cost). Objective: To assess a pilot platform by evaluating training, registry use and device management, utility for routine immunization, vaccine logistics and Adverse Events Following Immunization (AEFI) data, and routine immunization data quality in the DHIS2 mobile application compared with paper registers. Methods: Using the Public Health Informatics Institute’s Collaborative Requirements Development Methodology, stakeholders defined requirements, trained users and implemented a pilot. Mixed methods were used; a mini data audit was performed, and qualitative data were collected across 19 facilities in Montserrado, Gbarpolu and Grand Bassa. Seventy-eight health workers were trained to use the DHIS2 mobile application. Results: The future state design replaces paper aggregation steps with real-time mobile entry to a national registry and dashboard. Dual entry persisted during high-volume periods. The mini data audit found discrepancies between facility paper registers and DHIS2-EIR entries for child enrollment data and, Bacillus Calmette Guérin and Diphtheria–Pertussis–Tetanus dose administration records Participants attributed these discrepancies to internet and device problems and challenges navigating the system. Participants requested a training manual, improved connectivity at point of service, integration with supportive supervision, additional staff and system features (field to record hospital number, automated next visit date, and vaccination status prompts). Conclusions: Lessons from the pilot will inform country-wide implementation, including planned linkage with electronic birth and death registration to enable a unique child identifier and reduce manual errors and delays. Full article

Background/Objective: Dietary polysaccharides are increasingly recognized as functional nutritional components that support human health through modulation of immune function. However, clinical evidence linking their intake to site-specific upper respiratory mucosal immune health in humans remains limited. This study investigated whether dietary β-1,3/1,6-glucan (SC-BG) from baker’s yeast may support upper respiratory mucosal immune health in healthy adults. Methods: Following in vitro assays on human dendritic cells (DCs), a randomized, double-blind, placebo-controlled parallel-group trial was performed in healthy adults (18–69 years) who consumed either SC-BG or placebo capsules for 12 weeks in Japan. The primary outcome was circulating DC activation. Secondary outcomes were mucosal immune markers including secretory immunoglobulin A (s-IgA) and lysozymes from site-specific mucosal swabs (posterior oropharyngeal wall/nasopharynx) and salivar, and self-perceived upper respiratory tract symptoms. Results: SC-BG increased CD80 expression in DCs in vitro. In the clinical trial, 40 participants were randomized (n = 20 per group), and 39 (SC-BG: n = 19, placebo: n = 20) were analyzed. At week 8, the SC-BG group showed higher cDC1 CD80 expression than placebo. SC-BG intake also attenuated declines in s-IgA levels in the posterior oropharyngeal wall and nasopharynx and increased salivary lysozyme concentrations. Participants receiving SC-BG reported fewer cumulative days with upper respiratory tract-related local and systemic symptoms. No test food-related adverse events were observed. Conclusions: These findings provide preliminary clinical and mechanistic observations suggesting that dietary SC-BG may enhance circulating cDC1 activation and may help support upper respiratory local mucosal immune health in healthy adults, highlighting the potential of dietary polysaccharides as functional nutritional strategies for maintaining immune resilience. Full article

Background: Transarterial chemoembolization (TACE) is an established image-guided, minimally invasive therapy for unresectable hepatocellular carcinoma (HCC). However, post-embolization hypoxia often triggers compensatory angiogenesis and an immunosuppressive microenvironment, limiting long-term efficacy. We hypothesized that the immediate image-guided hepatic arterial infusion (HAI) of a PD-1 inhibitor following TACE could synergistically enhance local tumor control. Methods: In this retrospective, propensity-score-matched study, 226 patients with unresectable HCC (January 2021–June 2024) were analyzed. After 1:1 matching, 84 pairs were included: Study Group (TACE + HAI-nivolumab) and Control Group (TACE alone). Nivolumab (3 mg/kg) was infused via the hepatic artery under fluoroscopic guidance immediately after embolization. Primary endpoints were overall survival (OS) and progression-free survival (PFS); secondary endpoints included objective response rate (ORR) by mRECIST and changes in serum angiogenesis/immune biomarkers. Results: The Study Group demonstrated significantly longer median OS (16.2 vs. 12.8 months; HR 0.62, 95% CI: 0.44–0.88, p = 0.007) and median PFS (9.8 vs. 6.5 months; p < 0.001). ORR was higher with combination therapy (58.3% vs. 36.9%, p = 0.006). Mechanistically, HAI-nivolumab suppressed the post-TACE surge in VEGF and Ang-2 (p < 0.001) and increased the peripheral CD4+/CD8+ T-cell ratio. Grade 3/4 adverse events were comparable between groups (14.3% vs. 10.7%, p = 0.485). Conclusions: The image-guided combination of TACE with immediate HAI of nivolumab is associated with improved survival and tumor response in unresectable HCC. This strategy may counteract the adverse post-embolization microenvironment by simultaneously inhibiting angiogenesis and reactivating local immunity, representing an advanced image-guided combination therapy with strong translational relevance. Full article