RecruitingPhase 2NCT06393166

Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untreated Advanced Pancreatic Cancer

An Open-label, Single-arm, Multicenter, Phase II Clinical Study of the Efficacy and Safety of Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Patients With Untreated Advanced Pancreatic Cancer

Sponsor

Zhejiang Cancer Hospital

Enrollment

37 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Non-Resectable Pancreas Carcinoma

Summary

It is a single arm, open-label, multicenter, phase II cinical trial to evaluate the efficacy and safety of the Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection in first-line treatment of patients with Advanced or Metastatic Pancreatic Cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination chemotherapy regimen (alternating AG and mFOLFOX) together with two additional drugs — serplulimab (an immunotherapy) and bevacizumab (a drug that cuts off blood supply to tumors) — as a first-line treatment for advanced or metastatic pancreatic cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) confirmed by biopsy - You have not received any prior systemic treatment for advanced pancreatic cancer - You have at least one measurable tumor on imaging - You are in good health (ECOG score 0 or 1) with an expected survival of at least 12 weeks **You may NOT be eligible if...** - You have had prior treatment for advanced pancreatic cancer - You have serious heart, lung, or brain conditions - Your blood counts or organ function fall below required levels 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 Injection and Bevacizumab Injection

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.

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06393166

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