FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis
Recruiting now · Phase 2
Conditions studied: Colorectal Liver Metastasis (CRLM)
In brief
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
Key facts
- Study ID
- NCT06988852
- Run by
- Tongji Hospital
- People needed
- 300
- Starts
- 2023-05-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-05-25
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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