Actively Recruiting
Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV
Led by Dai, Guanghai · Updated on 2025-01-20
138
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Pancreatic cancer diagnosis confirmed by histopathology or cytology
- Unresectable disease based on multidisciplinary and imaging assessment
- Prior failed first-line therapy or recurrence within 6 months of (neo)adjuvant therapy
- No prior platinum-containing or irinotecan drugs in first-line therapy
- At least one measurable lesion per RECIST v1.1
- ECOG performance status 0-2
- Expected survival of at least 3 months
- Adequate bone marrow function with ANC 6 1.5 x 10^9/L, hemoglobin 60 g/dL, platelets 60 x 10^9/L, WBC 6 3.0 x 10^9/L
- Liver function within limits: ALT, AST, ALP 6 2.5x ULN or 5x ULN if liver metastases; total bilirubin <1.5x ULN
- Renal function with serum creatinine 6 1.5x ULN or creatinine clearance 6 60 mL/min
- Coagulation tests (PT, APTT, INR) 6 1.5x ULN
- Adequate biliary drainage if biliary obstruction present
- Prior therapy side effects recovered to grade 1 or baseline except alopecia and grade 2 or lower neuropathy
- Non-pregnant or lactating females; use effective contraception during and 6 months after study
- Ability to comply and provide informed consent
You will not qualify if you...
- Other malignancies within past 5 years except cured carcinoma in situ or basal cell skin cancer
- Uncontrolled pleural effusion or ascites
- Known brain or meningeal metastases
- Use of potent CYP3A4 or UGT1A1 inhibitors or inducers within 3 weeks before first dose
- Major organ surgery or elective surgery within 4 weeks before first dose (except minor procedures)
- Active, uncontrolled infections despite treatment
- Congenital or acquired immunodeficiency, active hepatitis with high viral load
- Serious uncontrolled diseases including diabetes, hypertension, cardiovascular, renal, hepatic failure, CNS disease, or mental disorders
- Grade >1 diarrhea with significant increase in bowel movements or severe stoma discharge
- Serum albumin 3 g/dL
- Participation in other clinical trials within 4 weeks prior to enrollment
- Investigator assessment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Beijing
Beijing, China
Not Yet Recruiting
2
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
G
Guanghai Dai
CONTACT
R
Ru Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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