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

RecruitingPhase 2Ages 18 Years - 75 YearsAllTongji Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 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
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What it tests

  • FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
  • hepatic arterial infusion chemotherapy (HAIC)
  • Bevacizumab
  • Cetuximab (Erbitux)
  • liver resection
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Where

1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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