Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT07286695
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.
Study:
NCT07286695
Study Brief:
Protocol Section:
NCT07286695