RecruitingPhase 3NCT07235930

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

Sponsor

Zhejiang Cancer Hospital

Enrollment

292 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

Non-Resectable Pancreas Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new multi-drug combination approach (sequential chemotherapy plus immunotherapy and a targeted therapy) against standard chemotherapy alone as a first treatment for people with advanced pancreatic cancer that has spread or cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) that has spread or cannot be surgically removed - You have not yet received any systemic (whole-body) treatment for this cancer - You have measurable tumors on imaging - You are in good overall health (ECOG 0 or 1) **You may NOT be eligible if...** - You have received prior chemotherapy or immunotherapy for this cancer - You have serious organ function problems - Your expected survival is less than 12 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSequential 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.

DRUGAG 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

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT07235930

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