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

Conversion Treatment With Hepatic Arterial Infusion of Oxaliplatin, Leucovorin and Fluorouracil Plus Intravenous Bevacizumab or Cetuximab for Initially Unresectable Colorectal Liver Metastasis: A Prospective Study

This study is testing if a new combination of chemotherapy and targeted treatments can help people with colorectal cancer that has spread to the liver and can't be surgically removed, so they can eventually have surgery and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: bevacizumab, cetuximab, chemotherapy, radiation, Sintilimab
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06988852 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed colorectal liver metastasis who have not responded to prior systemic treatments.

Not a fit: Patients with extra-hepatic metastasis or those unable to tolerate chemotherapy or surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly increase the number of patients with unresectable CRLM who can undergo surgery, leading to improved survival rates.

How similar studies have performed: While there have been studies on conversion treatments for CRLM, this specific approach using FOLFOX-HAIC is novel and has not been extensively tested.

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 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 this trial is running

Wuhan, Hubei

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

Study contacts

• Study coordinator: Zhang Bi Xiang

Conditions Colorectal Liver Metastasis