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Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer

NCT04296019 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-11-03

No results posted yet for this study

Summary

This study was a randomized, controled, multicenter, phase II clinical study evaluating the efficacy and safety of fruquintinib as a maintenance therapy following first-line treatment for metastatic colorectal cancer. This study will include the patients with confirmed unresectable metastatic left-sided colon cancer with RAS mutation or right-sided colon cancer who achieved stable disease (SD) or partial response (PR) or complete response (CR) via palliative first-line treatment. It's expected to include 110 patients and they will be randomly stratified at 2:1 into fruquintinib group and observation group based on whether bevacizumab is used and the primary tumor site, using the Interactive Network Response System (IWRS). The random No. corresponds to the respective patient. The enrollment time is expected to be 18 months, followed up for 24 months.

Conditions

  • Colo-rectal Cancer

Interventions

DRUG

Fruquintinib

Maintenance therapy with fruquintinib ( 5 mg qd for 3 consecutive weeks, followed by discontinuation for 1 week).

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-07-01
Completion
2025-01-01

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 NCT04296019 on ClinicalTrials.gov