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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of cancer medicines to treat advanced colorectal cancer in patients whose disease has progressed after initial treatment. The study is testing a special way of giving a drug called liposomal irinotecan, along with other chemotherapy drugs (5-FU and leucovorin) and a targeted therapy called bevacizumab, to see how well this combination works and how safe it is as a second option after the first treatment stops working.

People who might be eligible for this study are adults with advanced colorectal cancer who have already been treated with a common chemotherapy containing oxaliplatin but whose cancer has grown despite that treatment. Participants need to be in generally good health, with normal organ function, and have at least one cancer spot that can be measured on scans. During the trial, patients will receive this combination treatment and have regular check-ups and imaging tests every six weeks to monitor how the cancer responds and to watch for side effects. Treatment will continue until the cancer gets worse, side effects become too difficult to manage, or the patient or doctor decides to stop. Women of childbearing age and men will need to use effective birth control during the study and for a short time afterward. This study is currently recruiting patients and aims to find out if this treatment approach can help control advanced colorectal cancer better than existing options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed the informed consent；
• • 2. Male or female patients ≥18 years old;
• • 3. ECOG physical status score is 0 or 1;
• • 4. Patients with pathologically confirmed advanced colorectal carcinoma (all other histological types excluded);
• • 5. Patients who experienced disease progression under either of the following circumstances:During or within 6 months after first-line oxaliplatin-containing chemotherapy, or within 1 year after completing oxaliplatin-based adjuvant chemotherapy post-resection;
• • 6. Expected survival time ≥ 3 months;
• • 7. Patients must have at least one measurable metastatic lesion according to RECIST version 1.1;
• 8. Normal organ function:
• • 1. Hematology :Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); Platelet count ≥ 100 × 109/L (100000/mm3); Hemoglobin ≥ 90g/L;
• • 2. Kidney:The calculated value of creatinine clearance rate (CrCl) is ≥ 50 mL/min; Normal urine routine, urine protein\<2+or 24-hour (h) urine protein quantification\<1.0 g;
• • 3. Liver:Total serum bilirubin (TBiL) ≤ 1.5 × ULN;AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT can be ≤ 5 × ULN;Serum albumin (ALB) ≥ 30g/L;
• • 4. Normal coagulation function, international standardized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
• • 9. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For males, surgical sterilization or agreement to use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication should be considered;
• • 10. Comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study;
• Exclusion Criteria:
• • 1. History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
• • 2. Participation in other drug trials within 4 weeks prior to enrollment;
• • 3. Uncontrolled hypertension (SBP \>160 mmHg or DBP \>100 mmHg);
• • 4. Acute coronary syndrome (including MI/unstable angina) with coronary angioplasty/stent placement within 6 months;
• • 5. NYHA class II+ heart failure, unstable angina, MI, or severe arrhythmia with cardiovascular impairment within 6 months;
• • 6. Symptomatic brain metastases;
• • 7. Severe comorbidities requiring hospitalization (e.g., ileus, bowel obstruction, pulmonary fibrosis, refractory diabetes, heart/kidney/liver failure, psychiatric/cerebrovascular disorders);
• • 8. Gastrointestinal perforation/fistula, intra-abdominal abscess, or non-GI fistula within 6 months;
• • 9. Concomitant use of strong CYP3A4/CYP2C8 inhibitors/inducers or UGT1A1 inhibitors within 2 weeks;
• • 10. Pregnancy or lactation;
• • 11. Other investigator-determined contraindications.