Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients — SUNLIGHT

Refractory Metastatic Colorectal Cancer Clinical Trial

Official title:
An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)

Status Completed

Clinical Trial Summary

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

Clinical Trial Description

This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm). ;

Study Design

Related Conditions & MeSH terms

Colorectal Neoplasms
Refractory Metastatic Colorectal Cancer

Clinical Trial Details

NCT number	NCT04737187
Study type	Interventional
Source	Taiho Oncology, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	November 25, 2020
Completion date	September 12, 2023

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04527068` - QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer	Phase 2
Recruiting	`NCT05248048` - NKG2D CAR-T Cells to Treat Patients With Previously Treated Liver Metastatic Colorectal Cancer	Early Phase 1
Active, not recruiting	`NCT05205330` - A Phase Ib/IIa Study of CR6086 in Combination With Balstilimab in pMMR-MSS Metastatic Colorectal Cancer Patients	Phase 1/Phase 2
Active, not recruiting	`NCT05733611` - RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC	Phase 2
Recruiting	`NCT05991102` - Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer	N/A
Recruiting	`NCT05213195` - NKG2D CAR-NK Cell Therapy in Patients With Refractory Metastatic Colorectal Cancer	Phase 1
Completed	`NCT02860546` - A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC	Phase 2
Not yet recruiting	`NCT06343116` - Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer	Phase 3