Actively Recruiting
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
Led by West China Hospital · Updated on 2024-08-12
86
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.
CONDITIONS
Official Title
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Diagnosed with inoperable metastatic colorectal adenocarcinoma confirmed by histopathology
- Known RAS/BRAF v600e mutation or right half colon cancer
- Known pMMR/MSS status
- No prior systemic antitumor therapy for unresectable metastatic disease
- If previously treated with neoadjuvant or adjuvant therapy, disease progression occurred at least 6 months after last treatment
- ECOG performance status 0 to 1; patients 75 years or older must have ECOG 0
- At least one measurable lesion per RECIST v1.1 criteria
- Normal bone marrow and organ function as defined by specific blood and biochemical values
- Voluntary informed consent signed by patient or legal representative
You will not qualify if you...
- Known or suspected central nervous system metastasis
- Prior treatment with irinotecan, irinotecan liposomes, or bevacizumab
- Surgery or other oncologic treatments within 4 weeks before enrollment
- Previous treatment-related toxicity not resolved to grade 1 or below (except hair loss and peripheral neuropathy)
- Use of CYP3A, CYP2C8, or UGT1A1 inhibitors or inducers not discontinued at least 2 weeks before enrollment
- Severe gastrointestinal dysfunction such as perforation, intraperitoneal abscess, or fistula
- Intestinal obstruction or symptoms of obstruction, or implanted stent not removed before screening
- Interstitial lung disease
- History of arterial embolism or major bleeding within 6 months (except surgical bleeding)
- Unstable fluid accumulation; small asymptomatic ascites allowed
- Serious or uncontrolled systemic diseases including uncontrolled high blood pressure, heart disease, active bleeding, or viral infection
- Other malignancies within the past 5 years except certain cured cancers
- Women who are pregnant, breastfeeding, or of childbearing age refusing contraception
- Investigator judgment deeming participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital，Sichuan University
Sichuan, Sichuan, Chengdu, China, 610000
Actively Recruiting
Research Team
M
Meng Qiu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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