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Recruiting Phase 2 NCT06988852

FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis

Trial Parameters

Condition Colorectal Liver Metastasis (CRLM)
Sponsor Tongji Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-05-01
Completion 2030-12-31
Interventions
FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])hepatic arterial infusion chemotherapy (HAIC)Bevacizumab

Brief Summary

Try FOLFOX-HAIC combining bevacizumab or cetuximab for initially unresectable colorectal liver metastasis patients to increase the conversion to resection rate to improve long-term survival outcomes

Eligibility Criteria

Inclusion Criteria: * age 18-75 years * no history of other malignant diseases * refuse or progress in prior systemic treatment * diagnosed as CRLM confirmed by pathology, in spite of whether the primary tumor had been resected * at least one lesion in the liver could be measured * left ventricular ejection ≥45%, forced expiratory volume in one second/forced vital capacity≥60% and Eastern Cooperative Oncology Group (ECOG) score of 0-1 * Child-Pugh class A * adequate organ function, i.e.: white blood cell (WBC) ≥3.0×109/L, neutrophils ≥1.5×109/L, platelet (PLT) ≥75×109/L, total bilirubin ≤30μmol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤200U/L, creatinine ≤150μmol/L Exclusion Criteria: * extra-hepatic metastasis verified by medical imaging * unable to tolerate chemotherapy, anesthesia or surgery * allergy or previous intolerable to any agent of oxaliplatin, leucovorin, 5-Fu, bevacizumab or cetuximab * tumor spread in abdomen * cerebral infarction, cerebral

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