Combining fruquintinib with HAI-FOLFOX for treating refractory colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yuhong Li, PhD
• Email: liyh@sysucc.org.cn
• Phone: 87342487

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DSP107 plus atezolizumab versus fruquintinib for advanced colorectal cancer

  This test will see if giving DSP107 together with atezolizumab works better and is as safe as fruquintinib for adults with advanced microsatellite-stable colorectal cancer who have already tried standard treatments.

  Recruiting at 18 sites Phase 2 Kahr Medical · Aurora, Colorado and 17 other locations · NCT07235293

• Monitoring Fruzaqla treatment in adults with metastatic colorectal cancer in South Korea

  This project will track side effects, including serious ones, in adults in South Korea who are being treated with Fruzaqla (fruquintinib) for metastatic colorectal cancer.

  Recruiting Takeda · Seoul · NCT07035886

• Fruquintinib plus FOLFIRI for second-line metastatic colorectal cancer

  This study will test whether adding fruquintinib to FOLFIRI helps people with metastatic colorectal cancer who progressed after first-line FOLFOX plus bevacizumab.

  Recruiting at 14 sites Phase 2 SCRI Development Innovations, LLC · Denver, Colorado and 13 other locations · NCT07011576

• Fruquintinib with or without TAS-102 for refractory metastatic colorectal cancer

  This trial tests whether adding TAS-102 (Lonsurf) to fruquintinib helps people with microsatellite-stable, advanced or metastatic colorectal cancer that no longer responds to standard chemotherapy.

  Recruiting at 13 sites Phase 2 Criterium, Inc. · New Haven, Connecticut and 12 other locations · NCT06992258

• Evaluating fruquintinib's safety in minority groups with advanced colorectal cancer

  This study is testing if fruquintinib is safe for Black and Hispanic adults with advanced colorectal cancer who have already had treatment.

  Recruiting at 32 sites Phase 4 Takeda · Birmingham, Alabama and 44 other locations · NCT06562543

• Combining Fruquintinib, Regorafenib, and Sintilimab with Radiotherapy for Advanced Colorectal Cancer

  This study is testing a new combination of three cancer drugs with or without radiation to see if it helps people with advanced colorectal cancer who have already tried other treatments.

  Recruiting Phase 2 Shandong Cancer Hospital and Institute · Jinan, Shandong · NCT06356584

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.