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RECRUITING
NCT05963490
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2023-04-25

Completion Date

2026-04-25

Last Updated

2024-09-24

Healthy Volunteers

No

Interventions

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China