NCT06782685

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

Liposomal Irinotecan in Combination With Oxaliplatin and Bevacizumab Versus Liposomal Irinotecan in Combination With 5-FU/LV for the Second-line Treatment of Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Dai, Guanghai · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Advanced Pancreatic Cancer (Part 1)

Interventions

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

Timeline

• Start date: 2024-06-23
• Primary completion: 2026-07-01
• Completion: 2027-03-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

2 sites across 1 country: China