NCT07235930

Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer

Nab-Paclitaxel/Gemcitabine Followed by mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Previously Untreated Advanced Pancreatic Cancer: A Randomized, Controlled, Multicenter Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, multicenter, Phase III trial evaluating the efficacy and safety of first-line Sequential AG-mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab versus AG chemotherapy alone in advanced pancreatic cancer. The primary endpoint is Overall Survival (OS). Approximately 292 patients will be enrolled in China.

Detailed description

This is a randomized, open-label, multicenter, Phase III clinical trial designed to evaluate the efficacy and safety of first-line treatment with Sequential AG (Nab-paclitaxel/Gemcitabine) and mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab, versus AG chemotherapy alone, in patients with previously untreated, unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma. Approximately 292 eligible subjects will be randomized in a 1:1 ratio to receive either the experimental combination or the standard chemotherapy control. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination, with the primary endpoint being Overall Survival (OS) and key secondary endpoints including Progression-Free Survival (PFS), Objective Response Rate (ORR), and safety.

Conditions

• Non-Resectable Pancreas Carcinoma

Interventions

Type	Name	Description
DRUG	Sequential AG and mFOLFOX in Combination With Serplulimab and Bevacizumab	Nab-paclitaxel:125 mg/m2, ivgtt, D1, 8 and 15,every 6 weeks for a treatment cycle Gemcitabine hydrochloride: 1g/m2, ivgtt, D1, 8 and 15,every 6 weeks for a treatment cycle 5-FU: 2400 mg/m2 ,ivgtt over 46h, D29-30, every 6 weeks for a treatment cycle Oxaliplatin: 85 mg/m2 ,ivgtt, D29, every 6 weeks for a treatment cycle LV: 400 mg/m2 ,ivgtt over 2h, D29, every 6 weeks for a treatment cycle Serplulimab Injection: 3mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle. Bevacizumab Injection: 5mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle.
DRUG	AG chemotherapy	Nab-paclitaxel:125 mg/m2, ivgtt, D1, 8 and 15,every 4 weeks for a treatment cycle; Gemcitabine hydrochloride: 1g/m2, ivgtt, D1, 8 and 15, every 4 weeks for a treatment cycle

Timeline

• Start date: 2025-11-15
• Primary completion: 2029-07-01
• Completion: 2029-07-01
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: China