NCT07208539

AG Followed by FOLFIRINOX Both Combined With PD-L1 Antibodies as a Conversion Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer.

A Prospective, Double-cohort, Multicenter, Phase II Study of Gemcitabine and Albumin Paclitaxel in Combination With PD-L1 Antibodies Followed by Liposomal Irinotecan Combined With Oxaliplatin, 5-FU/LV and PD-L1 Antibodies as Conversion Therapy for Borderline Resectable/Local Advanced Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional study is to learn about the clinical efficacy of sequential therapy (albumin paclitaxel, gemcitabine combined with PD-L1 antibodies, followed by liposomal irinotecan, oxaliplatin and 5-FU/LV combined with PD-L1 antibodies). The main questions it aims to answer are: Does the sequential therapy increase the resection rate of borderline resectable / locally advanced pancreatic cancer? Does the sequential therapy represent an effective and safe treatment? Participants will receive two distinct chemotherapy regimens, each combined with a PD-L1 antibody, administered in sequence for two cycles each.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Treatment: AG & anti-PD-L1 + FOLFIRINOX & anti-PD-L1	The cohort A (borderline resectable) and cohort B (locally advanced) both received treatment with gemcitabine, albumin paclitaxel (administered on days 1, 8, and 15, with 4 weeks as one cycle) and adalimumab (administered once every 4 weeks, with 4 weeks as one cycle). After completing 2 cycles of treatment, they were sequentially given liposomal irinotecan combined with 5-FU/LV, oxaliplatin (administered once every 2 weeks, with 4 weeks as one cycle) and adalimumab (administered once every 4 weeks, with 4 weeks as one cycle). After completing 2 cycles of sequential treatment, surgical evaluation was conducted: for patients who could undergo radical surgical resection, surgery was performed within 2-4 weeks after the end of the conversion treatment stage, and the postoperative treatment plan was selected based on the investigator's judgment; for patients who could not undergo radical surgical resection, subsequent treatment plans could be selected based on the investigator's judgment.

Timeline

• Start date: 2025-10-10
• Primary completion: 2026-04-09
• Completion: 2026-12-31
• First posted: 2025-10-06
• Last updated: 2025-10-06