Fruquintinib Plus Arterial Infusion Therapy With Hepatic FOLFOX for Refractory Colorectal Cancer: The FAITH Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The objective of this clinical trial is to evaluate the efficacy and safety of combining fruquintinib with hepatic artery infusion (HAI)-FOLFOX in the treatment of refractory colorectal cancer with liver metastasis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Aged between 18 and 75 years.

• Histologically confirmed colorectal adenocarcinoma.

• Radiologically or pathologically confirmed liver metastasis.

• At least one measurable lesion (per RECIST v1.1 criteria).

• No extrahepatic metastasis confirmed by CT, MRI, or PET/CT (if necessary). Patients with minimal extrahepatic metastatic burden (defined as the presence of lung metastasis and/or lymph node metastasis with lung lesion diameter not exceeding 1 cm, and lymph node metastasis with the longest diameter less than 2 cm) can be included.

• Disease progression within 3 months or intolerance to standard treatment with fluoropyrimidine, irinotecan, oxaliplatin combined with targeted therapy (including bevacizumab and cetuximab (RAS/BRAF wild-type)), with previous oxaliplatin-induced neurotoxicity \< Grade 2.

• Normal hematologic function (platelets \>90×10\^9/L; white blood cells \>3×10\^9/L; neutrophils \>1.5×10\^9/L).

• Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 times ULN, no ascites, coagulation function: prothrombin time (PT) ≤1.5 ULN; international normalized ratio (INR) ≤1.5 ULN; activated partial thromboplastin time (APTT) ≤1.5 ULN, albumin ≥35 g/L.

• Child-Pugh grade A liver function.

• Serum creatinine less than ULN, or calculated creatinine clearance \>50 ml/min (using Cockcroft-Gault formula).

• ECOG performance status 0-1.

• Expected survival \>3 months.

• Signed written informed consent.

• Willing and able to undergo follow-up until death or study completion/termination.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yuhong Li, PhD
liyh@sysucc.org.cn
87342487
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 84
Treatments
Active_comparator: Fruquintinib monotherapy group (control group)
Participants in the fruquintinib monotherapy group will undergo a treatment cycle every 4 weeks, taking 5 mg orally once daily for 3 weeks, followed by a 1-week break.
Experimental: Fruquintinib plus HAI-FOLFOX treatment group (experimental group)
The experimental group will receive fruquintinib plus HAI-FOLFOX, with HAI-FOLFOX given every 2 weeks
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov