NCT04030260

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Metastatic
• MSS

Interventions

Type	Name	Description
DRUG	Regorafenib and PD-1 antibody in Combination with Radiotherapy	Regorafenib will be given 3 weeks on/1 week off (80 mg od po.) and PD-1 antibody
RADIATION	Radiation therapy	Radiation therapy is believed to increase the likelihood of response of immunotherapy

Timeline

• Start date: 2019-07-19
• Primary completion: 2023-02-20
• Completion: 2023-07-19
• First posted: 2019-07-23
• Last updated: 2023-03-23

Locations

1 site across 1 country: China