NCT05963490

Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

A Prospective, Randomized, Controlled Phase II Trial of Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab as Third-line Treatment in Patients With Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a total of 54 patients will receive regorafenib monotherapy. Experimental arm: a total of 54 patients will first receive 1 cycle of regorafenib and toripalimab followed by hypofractionated/low-dose radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy. The survival benefits, response rates, and adverse effects will be analyzed.

Detailed description

Control arm: regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle. Experimental arm: regorafenib is administered 80 mg once daily on days 1-21 of each 28 days cycle with intravenous toripalimab 240 mg every 3 weeks. Radiotherapy regimes include hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy).

Conditions

• Microsatellite Stable Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle.
DRUG	Toripalimab	240 mg intravenously every 3 weeks
RADIATION	Radiotherapy	hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy).
DRUG	Regorafenib	Regorafenib 80mg orally once daily on days 1-21 of each 28 days cycle.

Timeline

• Start date: 2023-04-25
• Primary completion: 2025-04-25
• Completion: 2026-04-25
• First posted: 2023-07-27
• Last updated: 2024-09-24

Locations

1 site across 1 country: China