Actively Recruiting
Liposomal Irinotecan with Oxaliplatin and Bevacizumab Versus Liposomal Irinotecan with 5-FU/LV for Second-Line Treatment of Advanced Pancreatic Cancer
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
Researchers are investigating treatments for advanced pancreatic cancer in patients who have not responded to first-line therapy. This clinical trial includes a Phase I study to find the best dose combination of liposomal irinotecan, oxaliplatin, and bevacizumab, followed by a Phase II study comparing the safety and effectiveness of this combination to a regimen of liposomal irinotecan with 5-FU and leucovorin. The goal is to improve treatment response rates and patient outcomes in this difficult-to-treat cancer. In Phase I, patients receive liposomal irinotecan starting at doses of 50mg/m2 or 60mg/m2 via 90-minute intravenous infusion on day 1, combined with oxaliplatin at doses of 60mg/m2 or 85mg/m2 on day 1, plus bevacizumab at 5mg/kg on day 1. Phase II uses the recommended Phase II doses of liposomal irinotecan and oxaliplatin plus bevacizumab every two weeks until disease progression or unacceptable side effects occur. The control group receives liposomal irinotecan at 70mg/m2 on day 1, calcium folinate at 400mg/m2 on day 1, and 5-FU at 2400mg/m2 by continuous infusion over 46 hours. Imaging is performed every 1.5 months to monitor disease status. Participants will be assessed regularly with imaging every three treatment cycles to evaluate tumor response. Researchers monitor safety and side effects closely, especially if patients stop treatment due to toxicity. Follow-up continues to track progression-free and overall survival. Total involvement includes repeated treatment cycles every two weeks, ongoing safety monitoring, and evaluations until progression or intolerance, aiming to optimize therapy for advanced pancreatic cancer patients.
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
Complete this quick 3-step screening to check your eligibility
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
R
Ru Jia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here