Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer

NCT06441565 | Recruiting Phase 2

• 1 other identifier: FAITH-CRC
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Hepatic Arterial Infusion Chemotherapy; Randomized Clinical Study; Progression Free Surivival; Safety Profile

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival

  The proportion of patients who remain alive and whose disease does not progress over a period of six months after starting treatment

  Assessed 6 months following treatment initiation

Secondary Outcomes (6)

• Liver Lesion Progression-Free Survival

  Assessed throughout the study duration (5 years)

• Extrahepatic Lesion Progression-Free Survival (PFS)

  Assessed throughout the study duration (5 years)

• Liver Lesion Objective Response Rate

  Assessed throughout the study duration (5 years)

• Extrahepatic Lesion Objective Response Rate (ORR)

  Assessed throughout the study duration (5 years)

• Overall Survival

  Assessed throughout the study duration (5 years)

Study Arms (2)

Fruquintinib monotherapy group (control group)

ACTIVE COMPARATOR

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.

Drug: Fruquintinib

Fruquintinib plus HAI-FOLFOX treatment group (experimental group)

EXPERIMENTAL

The experimental group will receive fruquintinib plus HAI-FOLFOX, with HAI-FOLFOX given every 2 weeks

Drug: Fruquintinib; Drug: Fluorouracil; Drug: Oxaliplatin

Interventions

Fruquintinib DRUG

A treatment cycle of 4 weeks, with 5 mg orally once daily for 3 weeks, followed by a 1-week break

Also known as: Fruzaqla

Fruquintinib monotherapy group (control group); Fruquintinib plus HAI-FOLFOX treatment group (experimental group)

Fluorouracil DRUG

2.8 g/m² (400mg bolus + 2.4g/m² continuous infusion) given every 2 weeks through hepatic arterial infusion

Also known as: 5-FU

Fruquintinib plus HAI-FOLFOX treatment group (experimental group)

Oxaliplatin DRUG

85 mg/m² given every 2 weeks through hepatic arterial infusion

Also known as: L01XA03

Fruquintinib plus HAI-FOLFOX treatment group (experimental group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013; Fluorouracil; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Yuhong Li, PhD

CONTACT

87342487; liyh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the fruquintinib monotherapy group (control group) or the fruquintinib plus HAI-FOLFOX treatment group (experimental group)

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 4, 2024
• Study Start: May 24, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2029
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CN (1)