A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC)
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Dokumenter
- Fultext
Forlagets udgivne version, 2,53 MB, PDF-dokument
The antitumor activity of chitooligosaccharides has been suggested. This phase 2 trial evaluated the efficacy and safety of T-ChOS™, in addition to adjuvant chemotherapy, in patients after resection of pancreatic ductal adenocarcinoma (PDAC). In this single-center, randomized, double-blind, placebo-controlled trial using patients ≥18 years of age after complete macroscopic resection for PDAC, patients were randomly assigned (1:1) to either a continuous oral T-ChOS group or a placebo group, in combination with gemcitabine (GEM) and oral capecitabine (CAP), for a maximum of six cycles. The primary endpoint was disease-free survival (DFS). Recruitment was stopped prematurely in July 2018, with 21 of planned 180 patients included, due to poor accrual and because modified FOLFIRINOX replaced GEM/CAP for the target population. Nine patients received T-ChOS and twelve received the placebo. The median DFS was 10.8 months (95% CI 5.9–15.7) for the T-ChOS arm and 8.4 months (95% CI 0–21.5) in the placebo arm. Overall, seven patients (78%) in the T-ChOS arm and eight patients (67%) in the placebo arm experienced at least one grade 3–4 treatment-related adverse event, most frequently neutropenia. Altogether, the addition of T-ChOS to chemotherapy in patients after resection of PDAC seems safe. However, the clinical benefit cannot be assessed due to the premature cessation of the trial.
Originalsprog | Engelsk |
---|---|
Artikelnummer | 509 |
Tidsskrift | Pharmaceutics |
Vol/bind | 14 |
Udgave nummer | 3 |
ISSN | 1999-4923 |
DOI | |
Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
Funding: The clinical trial was supported by the Department of Oncology, Herlev and Gentofte Hospital. Genis hf. provided T-ChOS™/placebo and funding for the trial.
Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.
ID: 310432790