NCT04695470

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Aiping Zhou · Unknown
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib and Sintilimab	fruquintinib 5mg qd for 2 weeks on and 1 week off, Q3w Sintilimab 200mg iv, Q3w

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2021-01-05
• Last updated: 2021-01-07

Locations

1 site across 1 country: China