Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebei Medical University Fourth Hospital
• Treatments: Bevacizumab; Fluorouracil; Irinotecan; Leucovorin

Criteria

Inclusion Criteria:

• Age: ≥18 years old.

• Histologically or cytologically proven colon or rectum adenocarcinoma.

• Confirmed as unresectable metastatic disease through radiological examination.

• At least one measurable lesion (according to RECIST v1.1).

• First-line treatment with oxaliplatin-based therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 2.

• The expected survival time ≥3 months.

• Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hgb) ≥90 g/L, white blood cell (WBC)≥3.0×10^9/L.

• Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present.

• Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL/min, proteinuria <2+.

• Normal coagulation function (INR≤1.5).

• Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.

Exclusion Criteria:

• Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.

• Previous treatment with irinotecan/liposomal irinotecan.

• Massive pleural effusion or ascites requiring intervention.

• Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.

• Active HIV, HBV, HCV infection.

• Combined with uncontrollable systemic diseases, such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; uncontrolled hypertension(Defined as systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg after treatment with standardized antihypertensive drugs), or history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes, etc.

• Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction , > grade 1 diarrhea or gastrointestinal perforation)

• History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrolment.

• Presence of interstitial pneumonia or pulmonary fibrosis.

• Allergy to or intolerance to therapeutic drugs or their excipients;.

• History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within one month prior to enrollment.

• Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before enrollment.

• Presence of central nervous system metastasis.

• Documented serum albumin ≤3 g/dL

• Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.

• Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.

• Participated in other trial within 30 days prior to the first dose of study treatment.

• Patients who are not suitable to participate in this trial for any reason judged by the investigator.