Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

NCT05842525 | Unknown Phase 2

• 1 other identifier: HNSZL-FK-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

RAS mutations are found in nearly half of colorectal cancer patients. However, except for G12C mutation, no driven gene targeted drug can be used. the commonly first-line used treatment regimen is bevacizumab combined with chemotherapy. Angiogenesis is an important therapeutic target in colorectal carcinoma. Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, has approved for the third-line treatment of refractory colorectal cancer.

Conditions

Colorectal Cancer

Keywords

Fruquintinib; RAS-mutant; second-line

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  the proportion of patients with complete response or partial response, using RECIST v 1.1

  assessed up to 1 year

Secondary Outcomes (1)

• Progression-Free Survival (PFS)

  assessed up to 1 year

Other Outcomes (2)

• Overall survival (OS)

  assessed up to 2 year

• Disease Control Rate (DCR)

  assessed up to 1 year

Study Arms (1)

study group

EXPERIMENTAL

Fruquintinib combined with FOLFIRI

Drug: intensive treatment; Drug: Maintenance treatment

Interventions

intensive treatment DRUG

Fruquintinib 4mg, orally, once daily, 3 weeks on/ 1 week off Irinotecan 150 mg/m2 LV 400 mg/m2 5-fluorouracil 400mg/m2 and a 46-48h continuous infusion 2400mg/m2 on day 1, q2w （intensive treatment up to 8 cycels）

study group

Maintenance treatment DRUG

Fruquintinib 5mg, orally, once daily, 3 weeks on/ 1 week off

study 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:

• Histological or cytological confirmed colorectal cancer;
• RAS mutation;
• Expected survival \>12 weeks;
• Patients had disease progression during or within 3 months of the last dose of first-line therapy, which must include bevacizumab combined with oxaliplatin, and a fluoropyrimidine;
• ECOG PS 0-1;
• At least one measurable lesion (according to RECIST1.1);
• Adequate hepatic, renal, heart, and hematologic functions;
• Negative serum pregnancy test at screening for women of childbearing potential.

You may not qualify if:

• MSI-H / dMMR;
• Received radiation therapy, surgical procedure, immunotherapy or other investigational drugs within 4 weeks prior to treatment ;
• Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc;
• Prior treatment with an irinotecan-based chemotherapy regimen;
• Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable);
• Severe infection (e.g., requiring intravenous antibiotics, antifungal drugs, or antiviral drugs) within 4 weeks prior to treatment;
• Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
• Patients who had active bleeding or coagulopathy within 2 months before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
• Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction \< 50%, arrhythmia control is not good;
• The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); Allergy to the study drug or any of its excipients;
• The patient is unable to take the drug orally, or the patient has a condition judged by the investigator to affect the absorption of the drug; Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Hutchison Medipharma Limited: collaborator

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Opiate Substitution Treatment

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)

Drug Therapy; Therapeutics

Study Officials

• zhenyang Liu, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhenyang Liu, MD PhD

CONTACT

0731-89762131; liuzhenyang@hnca.org.cn

xiaolin Yang, MD

CONTACT

0731-89762131'; yangxiaolin@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: October 1, 2023
• Primary Completion: May 28, 2024
• Study Completion: December 30, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)