Clinical Trials for Hepatobiliary and Pancreatic Cancer Diagnosis and Treatment

A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Clinical Research of Cancer".

Deadline for manuscript submissions: 31 December 2024 | Viewed by 3434

Special Issue Editor


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Guest Editor
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan
Interests: medical oncology; chemotherapy; targeted therapy; immunotherapy

Special Issue Information

Dear Colleagues,

Hepatobiliary and pancreatic cancer remain among the most challenging malignancies to treat. Of all the modalities available for the treatment of hepatobiliary and pancreatic cancer, only a few treatment modalities including resection and ablation therapy offer an opportunity to cure these conditions. However, in the majority of patients with hepatobiliary and pancreatic cancer, the cancer is already at an advanced and unresectable stage at the time of diagnosis. Even among patients with a curable disease, the long-term outcomes remain unsatisfactory, with 5-year survival rates remaining at a dismal around or below 50% owing to the high rate of recurrence even after treatment with a curative intent. Hence, novel clinical studies are needed to improve diagnostic and therapeutic strategies for the next decade.

This Special Issue will discuss the recent and ongoing clinical trials to establish a better diagnostic method to enable the detection of these types of cancer at an earlier stage, establish effective surgical or non-surgical treatments for patients with localized or systemic disease, and improve the quality of life for patients with such life-threatening diseases at any stage. This Special Issue invites researchers to submit reviews as well as original research articles by 31 October 2024.

Dr. Takuji Okusaka
Guest Editor

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Keywords

  • biliary cancer
  • liver cancer
  • pancreatic cancer
  • clinical trial
  • diagnosis
  • surgery
  • neoadjuvant therapy
  • adjuvant therapy
  • radiotherapy
  • chemotherapy
  • targeted therapy
  • precision medicine
  • immunotherapy
  • biliary and duodenal stent
  • psycho-oncology
  • palliative and supportive care

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Published Papers (3 papers)

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Research

12 pages, 590 KiB  
Article
Safety and Feasibility of Neoadjuvant-Modified FOLFIRINOX in Elderly Patients with Pancreatic Cancer
by Yoshitaro Shindo, Tatsuya Ioka, Yukio Tokumitsu, Hiroto Matsui, Masao Nakajima, Yuta Kimura, Yusaku Watanabe, Shinobu Tomochika, Yuki Nakagami, Ryouichi Tsunedomi, Michihisa Iida, Hidenori Takahashi and Hiroaki Nagano
Cancers 2024, 16(14), 2522; https://doi.org/10.3390/cancers16142522 - 12 Jul 2024
Viewed by 633
Abstract
The optimal treatment strategy for neoadjuvant chemotherapy in elderly patients with pancreatic cancer (PC) remains unclear. Hence, this study was aimed at evaluating the safety and feasibility of neoadjuvant-modified FOLFIRINOX (mFOLFIRINOX) in elderly patients with PC. We retrospectively collected data from 62 patients [...] Read more.
The optimal treatment strategy for neoadjuvant chemotherapy in elderly patients with pancreatic cancer (PC) remains unclear. Hence, this study was aimed at evaluating the safety and feasibility of neoadjuvant-modified FOLFIRINOX (mFOLFIRINOX) in elderly patients with PC. We retrospectively collected data from 62 patients who received neoadjuvant mFOLFIRINOX between May 2015 and October 2023 and comparatively analyzed the clinicopathological data and outcomes between the non-elderly group (age: <75 years) and elderly group (age: >75 years). The non-elderly and elderly groups comprised 39 and 23 patients, respectively. Although elevated levels of aspartate aminotransferase (p = 0.0173) and alanine aminotransferase (p = 0.0378) and nausea (p = 0.0177) were more frequent in the elderly group, the incidence of severe adverse events was similar between the groups. Intergroup differences in resection rate (p = 0.3381), postoperative severe complication rates (p = 0.2450), and postoperative hospital stay (p = 0.3496) were not significant. Furthermore, no significant intergroup differences were found in survival in either the whole or the resection cohorts. The perioperative and postoperative outcomes of elderly patients treated with neoadjuvant mFOLFIRINOX were comparable with those of non-elderly patients. Neoadjuvant mFOLFIRINOX should be considered a feasible option for elderly patients with PC. Full article
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14 pages, 1567 KiB  
Article
Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 1b/2 Trial of Nabpaclitaxel + Gemcitabine ± Olaratumab in Treatment-Naïve Participants with Metastatic Pancreatic Cancer
by Faithlore P. Gardner, Zev A. Wainberg, Christos Fountzilas, Nathan Bahary, Mark S. Womack, Teresa Macarulla, Ignacio Garrido-Laguna, Patrick M. Peterson, Erkut Borazanci, Melissa Johnson, Matteo Ceccarelli and Uwe Pelzer
Cancers 2024, 16(7), 1323; https://doi.org/10.3390/cancers16071323 - 28 Mar 2024
Cited by 1 | Viewed by 1363
Abstract
The efficacy and safety of olaratumab plus nabpaclitaxel and gemcitabine in treatment-naïve participants with metastatic pancreatic ductal adenocarcinoma was evaluated. An initial phase 1b dose-escalation trial was conducted to determine the olaratumab dose for the phase 2 trial, a randomized, double-blind, placebo-controlled trial [...] Read more.
The efficacy and safety of olaratumab plus nabpaclitaxel and gemcitabine in treatment-naïve participants with metastatic pancreatic ductal adenocarcinoma was evaluated. An initial phase 1b dose-escalation trial was conducted to determine the olaratumab dose for the phase 2 trial, a randomized, double-blind, placebo-controlled trial to compare overall survival (OS) in the olaratumab arm vs. placebo arms. In phase 1b, 22 participants received olaratumab at doses of 15 and 20 mg/kg with a fixed dose of nabpaclitaxel and gemcitabine. In phase 2, 159 participants were randomized to receive olaratumab 20 mg/kg in cycle 1 followed by 15 mg/kg in the subsequent cycles (n = 81) or the placebo (n = 78) on days 1, 8, and 15 of a 28-day cycle, plus nabpaclitaxel and gemcitabine. The primary objective of the trial was not met, with a median OS of 9.1 vs. 10.8 months (hazard ratio [HR] = 1.05; 95% confidence interval [CI]: 0.728, 1.527; p = 0.79) and the median progression-free survival (PFS) was 5.5 vs. 6.4 months (HR = 1.19; 95% CI: 0.806, 1.764; p = 0.38), in the olaratumab vs. placebo arms, respectively. The most common treatment-emergent adverse event of any grade across both arms was fatigue. Olaratumab plus chemotherapy failed to improve the OS or PFS in participants with metastatic PDAC. There were no new safety signals. Full article
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11 pages, 1332 KiB  
Article
C-Reactive Protein-to-Albumin Ratio to Predict Tolerability of S-1 as an Adjuvant Chemotherapy in Pancreatic Cancer
by Naotake Funamizu, Akimasa Sakamoto, Takahiro Hikida, Chihiro Ito, Mikiya Shine, Yusuke Nishi, Mio Uraoka, Tomoyuki Nagaoka, Masahiko Honjo, Kei Tamura, Katsunori Sakamoto, Kohei Ogawa and Yasutsugu Takada
Cancers 2024, 16(5), 922; https://doi.org/10.3390/cancers16050922 - 25 Feb 2024
Viewed by 922
Abstract
Adjuvant chemotherapy (AC) with S-1 after radical surgery for resectable pancreatic cancer (PC) has shown a significant survival advantage over surgery alone. Consequently, ensuring that patients receive a consistent, uninterrupted S-1 regimen is of paramount importance. This study aimed to investigate whether the [...] Read more.
Adjuvant chemotherapy (AC) with S-1 after radical surgery for resectable pancreatic cancer (PC) has shown a significant survival advantage over surgery alone. Consequently, ensuring that patients receive a consistent, uninterrupted S-1 regimen is of paramount importance. This study aimed to investigate whether the C-reactive protein-to-albumin ratio (CAR) could predict S-1 AC completion in PC patients without dropout due to adverse events (AEs). We retrospectively enrolled 95 patients who underwent radical pancreatectomy and S-1 AC for PC between January 2010 and December 2022. A statistical analysis was conducted to explore the correlation of predictive markers with S-1 completion, defined as continuous oral administration for 6 months. Among the 95 enrolled patients, 66 (69.5%) completed S-1, and 29 (30.5%) failed. Receiver operating characteristic curve analysis revealed 0.05 as the optimal CAR threshold to predict S-1 completion. Univariate and multivariate analyses further validated that a CAR ≥ 0.05 was independently correlated with S-1 completion (p < 0.001 and p = 0.006, respectively). Furthermore, a significant association was established between a higher CAR at initiation of oral administration and acceptable recurrence-free and overall survival (p = 0.003 and p < 0.001, respectively). CAR ≥ 0.05 serves as a predictive marker for difficulty in completing S-1 treatment as AC for PC due to AEs. Full article
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