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Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC

NCT06427005 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-01-22

No results posted yet for this study

Summary

Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients.

Conditions

Interventions

DRUG

Fruquintinib

Fruquintinib 5 mg daily for 14 days followed by a 7-day break

DRUG

S-1

S-1 80-120 mg daily for 14 days, followed by a 7-day break

DRUG

raltitrexed

raltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg

Sponsors & Collaborators

  • Beijing Xisike Clinical Oncology Research Foundation

    collaborator UNKNOWN

  • Meng Qiu

    lead OTHER

Principal Investigators

  • Meng Qiu, MD. · Sichuan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2025-08-18
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06427005 on ClinicalTrials.gov