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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT07235930
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non-Resectable Pancreas Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sequential AG and mFOLFOX in Combination With Serplulimab and Bevacizumab — DRUG
    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.
  • AG chemotherapy — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 15, 2025
Status verified
Nov 2025
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
292 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Sequential AG and mFOLFOX in Combination With Serplulimab and Bevacizumab
  • Active Comparator: Control group
    Standard AG chemotherapy

Primary Outcome Measure

Overall survival (OS) [ Time Frame: up to 36 months ]

Central Contacts