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Regorafenib and PD-1 Antibody in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

Official title:
Regorafenib and PD-1 Antibody in Combination With Radiotherapy With or Without SBRT in Patients With pMMR/MSS and Previously Treated Metastatic Colorectal Cancer

Clinical Trial Summary

REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36% and a progression-free survival (PFS) of 6.3 months. Based on the preliminary results of the REGONIVO study, the aim of this phase 2 study is to explore the safety and efficacy of regorafenib and PD-1 antibody with or without radiotherapy in previously treated metastatic colorectal cancer patients with pMMR/MSS.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04030260
Study type Interventional
Source Sun Yat-sen University
Contact Yanhong Deng, M.D.
Phone 86-13925106525
Email 13925106525@163.com
Status Recruiting
Phase Phase 2
Start date July 19, 2019
Completion date July 19, 2023
View Details
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