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

Launched by TONGJI HOSPITAL · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called FOLFOX-HAIC, which combines chemotherapy with two other medicines, bevacizumab or cetuximab, for patients who have colorectal liver metastasis (CRLM). This condition means that cancer from the colon or rectum has spread to the liver, and the tumors in the liver cannot be removed with surgery at the start of treatment. The goal of the trial is to see if this combination therapy can help shrink the tumors enough so that surgery becomes possible, ultimately aiming to improve long-term survival for patients.

To participate in the trial, applicants must be between 18 and 75 years old, have confirmed CRLM, and meet specific health criteria, including adequate organ function and no other active cancers. Participants will receive the treatment and be monitored for its effectiveness and any side effects. This trial is currently recruiting patients, and it provides an important opportunity for those who have not had success with previous treatments for this serious condition.

Gender

ALL

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