Phase II Trial of Fruquintinib With Sintilimab in Treating Selected Refractory Metastatic Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title: Phase II Trial of Fruquintinib With Sintilimab in Treating Refractory Metastatic Colorectal Cancer Patients With TMB(Tumor Mutation Burden)-High and Non-MSI(Microsatellite Instability)-High

Status Recruiting

Clinical Trial Summary

This is a prospective, Single arm Phase II trial. Patients were eligible to participate when they had histological or cytological confirmed metastatic colorectal adenocarcinoma Non-MSI(microsatellite instability)-high and TMB(tumor mutational burden)-High.

Patients had to have received at least a second-line standard therapy, including fluoropyrimidine, oxaliplatin, or irinotecan-based regimens and VEGF(vascular endothelial growth factor) inhibitors and to have disease progression within 3 months after the last administration of the last standard therapy or to have stopped such therapy due to unacceptable toxicities. Pre-treatment with anti-EGFR(epidermal growth factor receptor) were mandatory if RAS(Rat sarcoma virus) wild and left side .

Patients who met the eligibility criteria took fruquintinib plus Sintilimab until disease progression, death, unacceptable toxicity, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest. The primary study endpoint was PFS(progression free survival) rate at 6 months.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT04695470
• Study type: Interventional
• Source: Chinese Academy of Medical Sciences
• Contact: Aiping Zhou, MD
• Phone: 8610-87788145
• Email: zhouap1825@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Completion date: June 30, 2022