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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT06393166
Phase
PHASE2
Status
Unknown

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 Injection and Bevacizumab Injection — 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.

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Apr 2024
Primary completion
May 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sequential 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.

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: [ up to 12 months] ]

Central Contacts