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Spots Global Cancer Trial Database for Fruquintinib Sequential BEV+FOLFIRI vs. BEV+FOLFIRI Sequential Fruquintinib in Metastatic Colorectal Cancer

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Trial Identification

Brief Title: Fruquintinib Sequential BEV+FOLFIRI vs. BEV+FOLFIRI Sequential Fruquintinib in Metastatic Colorectal Cancer

Official Title: Fruquintinib Sequential BEV+FOLFIRI vs. BEV+FOLFIRI Sequential Fruquintinib in the Treatment of Metastatic Colorectal Cancer That Has Failed Previous Fluorouracil/Oxaliplatin Therapy

Study ID: NCT05447715

Interventions

Fruquintinib

Study Description

Brief Summary: This is a prospective, open, multicenter, randomized controlled phase II study designed to observe the difference of efficacy, adverse events and quality of life between second-line and third-line application of Fruquintinib in patients with metastatic colorectal cancer. The study will evaluate PFS, ORR, OS and safety.

Detailed Description: A maximum of 134 patients with metastatic colorectal cancer who had previously failed to receive fluorouracil/oxaliplatin were included in the study. The patients were randomly divided into two groups according to the ratio of 1:1 and given different medication regiments. Stratified factors included left and right colorectal cancer, tumor RAS gene status, and first-line use of bevacizumab. Specific grouping and medication regimen are as follows: Second-line treatment group (F-C group) : After enrollment, patients were given Fruquintinib 5 mg/d orally for 21 consecutive days with 7 days of rest, with a cycle of 28 days. Use drugs until the disease progresses or toxicity is intolerable, and then carry out third-line treatment. BEV+FOLFIRI was administered in the third line. Third-line medication until disease progression or toxicity becomes intolerable. Third-line application group (C-F group) : After enrollment, patients were treated with BEV+FOLFIRI until disease progression or toxicity intolerance, and third-line treatment was carried out after progression. Fruquintinib was given in the third line of treatment, specifically: Fruquintinib 5 mg/d orally for 21 consecutive days, followed by 7 days of rest, with a cycle of 28 days. Third-line medication until disease progression or toxicity becomes intolerable.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Fudan University Cancer Hospital, ShangHai, Shanghai, China

Contact Details

Name: Weijian Guo, MD

Affiliation: Fudan University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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