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

Colorectal Cancer Liver Metastases Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05485909
Study type	Interventional
Source	Sun Yat-sen University
Contact	Zhiqiang Wang
Phone	+8613825122020
Email	wangzhq@sysucc.org.cn
Status	Recruiting
Phase	Phase 2
Start date	July 25, 2022
Completion date	June 30, 2024

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