Study of CEB-01 Implant with Standard Surgery for Treating Locally Resectable Pancreatic Cancer in Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of the CEB-01 implant in adults with locally resectable pancreatic cancer. CEB-01 is a membrane containing SN-38, an active chemotherapy metabolite, designed to be placed in the surgical bed after tumor removal to provide local and sustained chemotherapy release. The study is an exploratory, multi-center, randomized, single-blind clinical trial aiming to delay or prevent local cancer recurrence while maintaining manageable toxicity. Participants will be randomly assigned in a 21 ratio to receive either standard surgery plus the CEB-01 implant or standard surgery alone. The implant is a biocompatible and biodegradable nanofiber membrane made of PLGA loaded with SN-38, placed after tumor removal. The trial includes a screening period up to 35 days, one day for surgery, and approximately three years of follow-up for safety and efficacy assessments. Blood samples will be collected at baseline and multiple times up to about 43 days post-surgery to assess pharmacokinetics. During the study, participants will be monitored for adverse events, surgical complications, and cancer recurrence through assessments over an average of three years. Researchers will measure local recurrence-free survival, progression-free survival, overall survival, and pharmacokinetic parameters such as drug concentration and half-life. Follow-up visits will evaluate the long-term therapeutic effect of CEB-01, with detailed safety monitoring throughout the trial duration.

CEB-01 in Locally Resectable Pancreatic Cancer