Combining fruquintinib with HAI-FOLFOX for treating refractory colorectal cancer
Fruquintinib Plus Arterial Infusion Therapy With Hepatic FOLFOX for Refractory Colorectal Cancer: The FAITH Randomized Clinical Trial
This study tests whether combining a new drug called fruquintinib with a specific chemotherapy method can help people with colorectal cancer that hasn't responded to other treatments live longer and feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | bevacizumab, cetuximab, chemotherapy, fruquintinib, sintilimab, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06441565 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of fruquintinib in combination with hepatic artery infusion (HAI)-FOLFOX for patients with refractory colorectal cancer that has spread to the liver. The study aims to improve progression-free survival and overall survival rates in patients who have not responded to standard treatments. Participants will be randomly assigned to receive either the combination treatment or a control. The trial focuses on patients with specific eligibility criteria, including age, cancer type, and previous treatment responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed colorectal adenocarcinoma and liver metastasis who have experienced disease progression after standard treatments.
Not a fit: Patients with extrahepatic metastasis beyond minimal lung or lymph node involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with refractory colorectal cancer and liver metastasis.
How similar studies have performed: Previous studies have shown promising results with fruquintinib in treating refractory colorectal cancer, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Severe arterial embolism. * Bleeding tendency or coagulation disorders. * Hypertensive crisis or hypertensive encephalopathy. * Severe uncontrolled systemic complications such as infection or diabetes. * Clinically significant cardiovascular diseases such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medical therapy, unstable angina, congestive heart failure (NYHA Class 2-4), or arrhythmias requiring medication. * History or physical examination indicative of central nervous system diseases (e.g., primary brain tumors, uncontrolled seizures, any history of brain metastasis or stroke). * Other malignancies within the past 5 years (except for radically treated basal cell carcinoma of the skin and/or carcinoma in situ of the cervix). * Received any investigational drug treatment within 28 days prior to the study. * Residual toxicity from previous chemotherapy (excluding alopecia), such as peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0), if considering an oxaliplatin-containing regimen. * Allergy to any of the study drugs. * Pregnant or breastfeeding women. * Women of childbearing potential not using or refusing to use effective non-hormonal contraception (intrauterine device, barrier method combined with spermicide, or sterilization) or men with reproductive potential. * Inability or unwillingness to comply with the study protocol. * Presence of any other diseases, functional impairment due to metastatic lesions, or findings on physical examination suggesting a contraindication to the use of the study drugs or putting the participant at high risk for treatment-related complications.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yuhong Li, PhD
- Email: liyh@sysucc.org.cn
- Phone: 87342487
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.