Actively Recruiting
Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC
Led by Affiliated Hospital of Nantong University · Updated on 2025-01-28
30
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.
CONDITIONS
Official Title
Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Confirmed diagnosis of inoperable advanced metastatic colorectal cancer (stage IV)
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Prior failure or intolerance to first- or second-line oxaliplatin-based therapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival time of 3 months or more
- Adequate organ function confirmed by laboratory tests within 14 days before treatment
- Previous antineoplastic therapies stopped for at least 4 weeks and related side effects resolved or stable
- Negative pregnancy test and agreement to use contraception for women of childbearing age and their partners
- Voluntary participation with signed informed consent and ability to comply with study requirements
You will not qualify if you...
- History of other malignant tumors within 5 years, except certain low-risk cancers
- Tumors with mismatch repair defects or high microsatellite instability suitable for immune checkpoint inhibitors
- Presence of BRAF V600E mutation indicating poor chemotherapy prognosis
- Known or suspected central nervous system metastases
- Previous treatment with irinotecan or irinotecan liposome chemotherapy
- Use of strong CYP3A4, CYP2C8, or UGT1A1 inhibitors or inducers within 14 days before study
- Participation in other drug clinical trials within 4 weeks before treatment
- Severe gastrointestinal dysfunction or inflammation beyond specified grades
- Severe comorbidities, active infections, or uncontrolled medical conditions that interfere with treatment
- Grade 2 or higher peripheral neuropathy
- Known allergy or intolerance to study drugs or excipients
- Pregnancy, breastfeeding, or refusal to use contraception
- Any other condition judged by the investigator to prevent safe participation or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital Of Nantong University
Nanjing, Jiangsu, China, 025
Actively Recruiting
Research Team
X
Xiancheng X Liu, Master
CONTACT
H
Hongmei H Gu
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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