RecruitingPhase 2NCT05963490

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


Sponsor

Fudan University

Enrollment

108 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of regorafenib (a targeted cancer drug), low-dose radiation therapy, and toripalimab (an immunotherapy drug that helps the immune system attack cancer) for patients with metastatic colorectal cancer (cancer that has spread) that has not responded to previous treatments. **You may be eligible if...** - You are 18 or older with confirmed colorectal cancer that has spread - Your cancer is MSS/pMMR type (a molecular classification) - You have at least one tumor site suitable for radiation - Your overall health is adequate for treatment (ECOG 0–1, life expectancy at least 3 months) - You have already received standard chemotherapy regimens **You may NOT be eligible if...** - Your cancer has not been treated with standard chemotherapy first - You have autoimmune disease or are on immune-suppressing medications - You have untreated brain metastases - Your organ function is too poor for chemotherapy or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRegorafenib

Regorafenib 120 mg orally once daily on days 1-21 of each 28 days cycle.

DRUGToripalimab

240 mg intravenously every 3 weeks

RADIATIONRadiotherapy

hypofractionated radiotherapy (5 fractions of 4-12Gy) and low-dose radiotherapy (5 fractions of 0.5-2Gy).

DRUGRegorafenib

Regorafenib 80mg orally once daily on days 1-21 of each 28 days cycle.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT05963490


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