Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV

Sponsor
Dai, Guanghai
Study ID
NCT06782685
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Pancreatic Cancer (Part 1)

Eligibility Criteria

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

Interventions

  • Irinotecan liposoma — DRUG
    Exploration started with 50mg/m\^2 dose, preset 50mg/m\^2, 60mg/m\^2, 2 dose groups, IV infusion 90min, d1
  • oxaliplatin — DRUG
    Exploration started with 60mg/m\^2 dose, preset 60mg/m\^2, 85mg/m\^2, 2 dose groups, IV infusion, d1
  • bevacizumab — DRUG
    5mg/kg，i.v.，d1
  • 5-FU — DRUG
    2400mg/m\^2, i.v.，46h
  • LV — DRUG
    400mg/m\^2, i.v.，d1
  • Irinotecan Liposomal — DRUG
    70mg/m\^2, i.v.，d1
  • Irinotecan Liposomal — DRUG
    Phase II recommended dose
  • Oxaliplatin — DRUG
    Phase II recommended dose

Study Details

Purpose of the study Phase I study: to explore the optimal dose combination of irinotecan liposome + oxaliplatin + bevacizumab regimen, irinotecan liposome + oxaliplatin Phase II study: to evaluate the safety and efficacy of the second-line treatment regimen of irinotecan liposome combined with oxaliplatin and bevacizumab compared to the second-line treatment regimen of irinotecan liposome combined with 5-FU/LV in advanced pancreatic cancer Sample size 138 cases Phase I Crawl, sample size 9-18 cases. Phase II randomized controlled clinical study, historical data NAPOLI-1 study, ORR of 8.8% for irinotecan liposome + 5-FU/LV, planned trial arm ORR upgrade to 25%, calculated at 60 cases in each arm. Subject population Patients with advanced pancreatic cancer diagnosed after failure of first-line therapy, confirmed by histopathology or cytopathology, who meet the inclusion criteria and do not meet the exclusion criteria. Phase I design: Liposomal irinotecan + oxaliplatin + bevacizumab, 2-week regimen Liposomal irinotecan: start exploring with 50mg/m2 dose, preset 50mg/m2, 60mg/m2, 2 dose groups, 90min IV infusion, d1; Oxaliplatin: explored from 60mg/m2 dose, preset 60mg/m2, 85mg/m2, 2 dose groups, IV infusion, d1; Bevacizumab: 5 mg/kg, i.v., d1; Phase II study design. Trial group: Irinotecan liposomal: RP2D, i.v., 90min, d1; Oxaliplatin: RP2D, i.v., d1; Bevacizumab: 5mg/kg, i.v., d1; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles/1.5 months. Control: Liposomal irinotecan: 70 mg/m2 IV for 90 min, d1; Calcium folinate: 400 mg/m2, IV infusion over 30 min, d1; 5-FU: 2400 mg/m2, continuous IV infusion over 46h; Cycles every 2 weeks until disease progression or intolerable; imaging every 3 treatment cycles/1.5 months. Notes: If the duration of irinotecan liposome infusion can be extended appropriately based on the patient\'s clinical response; if the patient withdraws from the trial due to intolerance of toxicity (e.g., neurotoxicity or myelotoxicity) induced by one of the drugs, follow up is required until PFS and OS. Translated with DeepL.com (free version)

Key Dates

Start date
Jun 23, 2024
Status verified
Jan 2025
Primary completion
Jul 31, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Irinotecan liposomal combination of oxaliplatin and bevacizumab
    To explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab and determine the recommended dose for phase II
  • Active Comparator: Irinotecan liposomal combination of 5-FU/LV
    Standard treatment
  • Experimental: Irinotecan liposomal +oxaliplatin +bevacizumab
    Phase II recommended dose

Primary Outcome Measure

To explore the optimal dose combination of irinotecan liposomes plus oxaliplatin in the regimen of irinotecan liposomes plus oxaliplatin in bevacizumab [ Time Frame: At the end of Cycle 1 (each cycle is 14 days) ]

Central Contacts