Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer

Phase 2

Not yet recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: Fruquintinib+ Lonsurf (trifluridine and tipiracil); Drug: Fruquintinib

• Registration Number: NCT06992258
• Lead Sponsor: Criterium, Inc.

Brief Summary

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Study Start: 2025-06-15
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fruquintinib and Lonsurf	Fruquintinib+ Lonsurf (trifluridine and tipiracil)	-
Fruquintinib	Fruquintinib	-

Primary Outcome Measures

Name	Time	Method
To estimate the progression-free survival (PFS) benefit of fruquintinib in combination with TAS-102 as compared to fruquintinib	24 months	Progression free survival (PFS) defined as time from randomization to first observation of progression using RECIST v1.1 or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Estimate the confirmed objective response rate (ORR) of fruquintinib in combination with TAS-102 as compared to fruquintinib	24 months	Objective response rate (ORR) defined as partial response or complete response using RECIST v1.1
Estimate the disease control rate (DCR) of fruquintinib in combination with TAS-102 as compared to fruquintinib	24 months	Disease control rate (DCR) defined as partial response, complete response, or stable disease using RECIST v1.1
Estimate the clinical benefit rate (CBR) of fruquintinib in combination with TAS-102 as compared to fruquintinib	24 months	Clinical benefit rate (CBR defined as the percentage of patients achieving a partial response, complete response, or stable disease for at least 6 months using RECIST v1.1
Estimate the overall survival (OS) of fruquintinib in combination with TAS-102 as compared to fruquintinib	24 months	Overall survival (OS) defined as time from randomization to death from any cause
Characterize the toxicity profile of fruquintinib in combination with TAS-102	24 months	Toxicity profile comprised of: Incidence of grade 3 or more treatment-related adverse events (TRAE), Percent of patients requiring dose reductions or dose delays due to TRAE, Percent of patients requiring treatment discontinuation due to TRAE