Phase II Study of HRS-4642 Combined With Nimotuzumab and Chemotherapy for Adults Aged 18 to 75 With Borderline Resectable Pancreatic Cancer and KRAS G12D Mutation

What this Trial Is About

Researchers are evaluating the effectiveness of a combination treatment using HRS-4642, Nimotuzumab, and chemotherapy AG regimen in adults with borderline resectable pancreatic cancer that has a specific KRAS G12D mutation. This is a Phase II clinical trial designed to study this combination in 40 patients and includes a screening period, treatment period, and follow-up period to monitor safety and survival. During the treatment phase, participants receive neoadjuvant therapy with HRS-4642 given intravenously on Days 1 and 8 every three weeks, Nimotuzumab on Days 1 and 8 every three weeks, and chemotherapy drugs albumin-bound paclitaxel and gemcitabine on Days 1 and 8 every three weeks for four cycles. After two and four cycles, imaging is done to evaluate response. If surgery is feasible after neoadjuvant therapy, participants undergo surgery followed by an adjuvant therapy phase with the same drug combination for up to four cycles. If surgery is not possible and the disease has not progressed, treatment may continue as assessed by the investigator. Participants have regular visits for treatment and assessments, including tumor imaging at specific cycles and intervals after surgery or if surgery is not performed. After treatment ends, participants return for a safety follow-up visit about 30 days later and enter a survival follow-up phase with monitoring every two months until death, loss to follow-up, or study termination. The primary outcome is the 12-month event-free survival rate, with other outcomes including overall survival, surgical rates, and response rates.

HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation