Actively Recruiting
Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-07-02
46
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR). Eligible subjects will receive second-line treatment with the FOLFIRInali-3 （Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV） plus bevacizumab (Bev) 。Treatment will be discontinued upon occurrence of any of the following: Disease progression (radiologically confirmed)，intolerable toxicity (unmanageable after dose modification)， initiation of new antitumor therapy, withdrawal of informed consent or investigator's discretion (based on clinical judgment). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
CONDITIONS
Official Title
Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the informed consent
- Male or female patients 18 years old or older
- ECOG physical status score of 0 or 1
- Pathologically confirmed advanced colorectal carcinoma (excluding other histological types)
- Disease progression during or within 6 months after first-line oxaliplatin-containing chemotherapy or within 1 year after completing oxaliplatin-based adjuvant chemotherapy post-resection
- Expected survival time of at least 3 months
- At least one measurable metastatic lesion according to RECIST version 1.1
- Normal organ function including:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 90 g/L
- Creatinine clearance rate (CrCl) ≥ 50 mL/min; normal urine routine; urine protein <2+ or 24-hour urine protein quantification <1.0 g
- Total serum bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis); Serum albumin ≥ 30 g/L
- Normal coagulation function: INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN
- Women of childbearing age must have a negative pregnancy test within 14 days before enrollment and agree to use contraception during the study and for 8 weeks after last treatment
- Males must agree to use contraception during the study and for 8 weeks after last treatment
- Ability to comply with scheduled visits, treatments, lab tests, and study requirements
You will not qualify if you...
- History of other malignancies except cured basal cell carcinoma or cervical carcinoma in situ
- Participation in other drug trials within 4 weeks before enrollment
- Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
- Acute coronary syndrome including myocardial infarction or unstable angina with coronary angioplasty/stent placement within 6 months
- NYHA class II or higher heart failure, unstable angina, myocardial infarction, or severe arrhythmia with cardiovascular impairment within 6 months
- Symptomatic brain metastases
- Severe comorbidities requiring hospitalization such as ileus, bowel obstruction, pulmonary fibrosis, refractory diabetes, heart/kidney/liver failure, psychiatric or cerebrovascular disorders
- Gastrointestinal perforation/fistula, intra-abdominal abscess, or non-GI fistula within 6 months
- Use of strong CYP3A4/CYP2C8 inhibitors/inducers or UGT1A1 inhibitors within 2 weeks
- Pregnancy or lactation
- Other contraindications determined by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
T
Ting Deng, 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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