Spots Global Cancer Trial Database for Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

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Trial Identification

Brief Title: Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

Official Title: Phase II Study of Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

Study ID: NCT05004831

Conditions

Metastatic Colorectal Cancer

Interventions

fruquintinib plus TAS-102

Study Description

Brief Summary: This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.

Detailed Description: This is a prospective, single center, one-arm phase II study. A total of 54 advanced mCRC patients refractory to standard therapies will be enrolled and administered with fruquintinib (4mg/d, qd po, D1-21, Q4W) combined with TAS-102 (70mg/m2/d, bid po, D1-5, 8-12, Q4W) until intolerable toxicity, disease progression or death. Primary endpoint of this study is PFS and secondary endpoints are OS, ORR, DCR and safety.