Using FOLFOX-HAIC to treat colorectal liver metastasis that can't be surgically removed

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of FOLFOX-HAIC, a combination of systemic chemotherapy and targeted agents, in patients with initially unresectable colorectal liver metastasis (CRLM). The goal is to increase the rate at which these patients can undergo surgical resection, thereby improving long-term survival outcomes. Participants will receive treatments including oxaliplatin, leucovorin, and 5-fluorouracil, along with either bevacizumab or cetuximab. The study aims to assess the conversion to resection rates and overall survival in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Zhang Bi Xiang
• Email: bixiangzhang@hust.edu.cn
• Phone: 862783663400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.