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

StatusRecruiting
PhasePhase 2
Started2024-01-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 9, 2024 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-10-07
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Design, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-12-31→2026-02-01
Completion date2025-12-31→2027-03-01
Enrollment target50→173
Study sites0→1
Eligibility criteria-251 characters
Inclusion Criteria: Age: ≥18-75 years old. Histologically or cytologically proven colon or [...] )≤1.5 x ULN or creatinine clearance ≥60 mL/min, proteinuria <&lt;2+. Normal coagulation function (INR≤1.5). Agree and be able [...] a. Previous treatment with irinotecan/liposomal irinotecan. MSI-H/dMMR Massive pleural effusion or ascites requiring intervention. [...] CV 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; uncontr [...] [...]
2023-12-24
Original filing
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.
Trial Details
NCT Number NCT06184698
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions Colorectal Cancer
Enrollment 173 participants
Start Date 2024-01-01
Primary Completion 2026-02-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-09