Status:
RECRUITING
FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis
Lead Sponsor:
Tongji Hospital
Conditions:
Colorectal Liver Metastasis (CRLM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
Detailed Description
Colorectal cancer (CRC) was a common malignancy. Approximately 50% CRC patients would develop either synchronous or metachronous liver metastasis, which served as the leading cause of death in CRC, du...
Eligibility Criteria
Inclusion
- 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
- 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 hemorrhage, gastrointestinal hemorrhage/perforation within 6 months, coagulation disorders and gastrointestinal ulcer
- primary tumor may not be completely resected
- prior treatment of CRLM with resection, ablation or radiation
- incomplete clinical or follow-up data
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06988852
Start Date
May 1 2023
End Date
December 31 2030
Last Update
May 25 2025
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030