Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-04 @ 7:49 PM
Study NCT ID:
NCT07286695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fruquintinib Combined With TAS-102 Versus Bevacizumab Combined With TAS-102 for Advanced Metastatic Colorectal Cancer
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
A Multicenter, Open-label, Randomized Controlled Study of Fruquintinib Combined With TAS-102 Versus Bevacizumab Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic Colorectal Cancer Who Failed Standard Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with chemotherapy. Trifluridine/tipiracil (TAS-102) plus bevacizumab is also a standard treatment for mCRC. This study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 versus bevacizumab combined with TAS-102 in the treatment of patients with advanced metastatic colorectal cancer who failed standard chemotherapy.
Detailed Description:
Phase II study comprises a safety run-in stage, and a randomized treatment stage.
Phase II (safety run-in stage): It aims to evaluate the safety and tolerability of combination therapy-comprising TAS-102 and fruquintinib. TAS-102 was administered at a descending dose level starting from 35 mg/m² each time alongside fixed dose of fruquintinib in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens.
Phase II (randomized treatment stage): Upon determination of the recommend dose of TAS-102 based on prior data, a randomized controlled study will be conducted in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens. Patients will be randomly assigned to two arms: experimental arm: Fruquintinib and TAS-102; active comparator arm: Bevacizumab and TAS-102.
Phase II (safety run-in stage): It aims to evaluate the safety and tolerability of combination therapy-comprising TAS-102 and fruquintinib. TAS-102 was administered at a descending dose level starting from 35 mg/m² each time alongside fixed dose of fruquintinib in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens.
Phase II (randomized treatment stage): Upon determination of the recommend dose of TAS-102 based on prior data, a randomized controlled study will be conducted in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens. Patients will be randomly assigned to two arms: experimental arm: Fruquintinib and TAS-102; active comparator arm: Bevacizumab and TAS-102.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: