NCT05485909

Phase II Study of Regorafenib and Toripalimab Combined With RFA in Patients With CRCLM

A Single-arm, Single-center Phase II Clinical Study of Regorafenib and Toripalimab Combined With Radiofrequency Ablation (RFA) in Patients With Colorectal Cancer Liver Metastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The incidence of colorectal cancer liver metastasis is high and the prognosis is poor. Improving the treatment effect of colorectal cancer liver metastasis is the key to improving the prognosis of colorectal cancer patients. Rigofenib is one of the standard third-line treatments for advanced colorectal cancer, but has limited efficacy. Immune checkpoint inhibitors (PD-L1 monoclonal antibody, PD-1 monoclonal antibody) have achieved good results in the treatment of various malignant tumors. In a mouse transplant tumor model of colorectal cancer, regorafenib combined with PD-1 monoclonal antibody treatment significantly improved the antitumor activity, but the efficacy rate in clinical studies was not very high, especially for liver metastases. Radiofrequency ablation (RFA) is one of the common methods for the treatment of liver metastases. RFA may improve the immune microenvironment and the efficacy of immunotherapy,and the purpose of this trial is to explore the efficacy and safety of rigofenib and terepliumab combined with RFA in patients with refractory colorectal cancer liver metastasis.

Conditions

• Colorectal Cancer Liver Metastases

Interventions

Type	Name	Description
OTHER	Radiofrequency ablation	For multiple intrahepatic lesions, select 1 to 2 lesions for radiofrequency ablation
DRUG	Regorafenib and Toripalimab Combination	Toripalimab 200 mg, iv drip, d1, d15, q4w, Regorafenib 80mg, po, d1-d21, Q4w.

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-07-30
• Completion: 2024-06-30
• First posted: 2022-08-03
• Last updated: 2022-08-03

Locations

1 site across 1 country: China