Tislelizumab combined with standard therapy for conversion treatment in patients with MSS, initially unresectable colorectal cancer liver metastases (CRLM): A prospective, phase II study.
Ying Yuan, Xuefeng Fang, Dan Li, Shanshan Weng, Hanguang Hu, Caixia Dong, Qian Xiao, Da Wang, Xiujun Liao, Jianwei Wang, Lifeng Sun, Dong Xu, Yongmao Song, Jun Li, Sheng Yan, Bo Zhou, Guogang Li, Suzhan Zhang, Ke-Feng DingTPS159
Background:
The liver is the most common site of metastasis in colorectal cancer, and liver metastases represent the primary cause of death among these patients. Achieving no evidence of disease (NED) to attain a disease-free state can significantly prolong overall survival. This study aims to evaluate the conversion rate and safety of adding tislelizumab to standard therapy regimens in patients with initially unresectable CRLM.
Methods:
This study enrolled patients with MSS-type CRLM. After the MDT assessed and confirmed potentially resectable disease, patients were stratified into two cohorts based on RAS status. The RAS wild-type cohort received tislelizumab combined with cetuximab and FOLFOX. The RAS mutant cohort received tislelizumab combined with bevacizumab and CAPOX. The primary endpoint was the conversion rate, and secondary endpoints included objective response rate (ORR), disease free survival (DFS) and safety. This clinical trial was registered at ClinicalTrials.gov (NCT05409417).