Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06988852

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

Led by Tongji Hospital · Updated on 2025-05-25

300

Participants Needed

1

Research Sites

400 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • No history of other malignant diseases
  • Refused or progressed after prior systemic treatment
  • Diagnosed with colorectal liver metastasis confirmed by pathology
  • At least one measurable liver lesion
  • Left ventricular ejection fraction ≥45%
  • Forced expiratory volume in one second/forced vital capacity ≥60%
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Child-Pugh class A liver function
  • Adequate organ function including WBC ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥75×10⁹/L, total bilirubin ≤30 μmol/L, ALT and AST ≤200 U/L, creatinine ≤150 μmol/L
Not Eligible

You will not qualify if you...

  • Extra-hepatic metastasis shown by medical imaging
  • Unable to tolerate chemotherapy, anesthesia, or surgery
  • Allergy or intolerance to oxaliplatin, leucovorin, 5-FU, bevacizumab, or cetuximab
  • Tumor spread in the abdomen
  • Cerebral infarction, cerebral hemorrhage, gastrointestinal hemorrhage or perforation within 6 months
  • Coagulation disorders or gastrointestinal ulcers
  • Primary tumor may not be completely resected
  • Prior treatment of colorectal liver metastasis with surgery, ablation, or radiation
  • Incomplete clinical or follow-up data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

Z

Zhang Bi Xiang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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