NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06345300
Phase
PHASE2
Status
Unknown

Conditions

  • Borderline Resectable Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab — DRUG
    The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Camrelizumab at a fixed dose of 200mg, administered via intravenous drip, with each infusion lasting no less than 30 min and no more than 60 min. Administered on day 1 of every 2-week cycle (d1, q2w). Each treatment cycle is 14 days, and all drugs are administered on day 1.
  • Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate — DRUG
    The treatment regimen for this study is as follows: Intravenous infusion of Oxaliplatin at a dose of 85mg/m2 for 2 hours or according to clinical practice at the research center; Intravenous infusion of liposomal Irinotecan at a dose of 60mg/m2 for 90 minutes (±30 min); Intravenous drip of Calcium folinate at a dose of 400mg/m2 for 30 minutes or according to clinical practice at the research center; Intravenous infusion of 5-Fluorouracil at a dose of 2400mg/m2 (infused for 46-48 hours or according to clinical practice at the research center); Each treatment cycle is 14 days, and all drugs are administered on day 1.

Study Details

The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer

Key Dates

Start date
Mar 10, 2024
Status verified
Dec 2023
Primary completion
Dec 12, 2024
Completion
Dec 24, 2025

Study Design

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

Arms

  • Experimental: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab
    Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab
  • Experimental: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
    Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate

Primary Outcome Measure

R0 resection rate [ Time Frame: 1 years ]

Central Contacts

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