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Clinical Trial Summary

This is an open-label phase II study, with the aim of investigating the efficacy and safety of Tislelizumab + Fruquintinib combination therapy in ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan. Patients with hypermutated CRC that carries POLE/POLD1 mutations cannot be included.


Clinical Trial Description

In this open-label phase II study, patients with ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan, will be scheduled for Tislelizumab (200mg ivdrip Q3W day1) + Fruquintinib (5mg/day Q3W day1-14) until intolerable toxicity, disease progression or death. Primary endpoint of this study is ORR and secondary endpoints are OS, PFS, DCR and safety. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05690035
Study type Interventional
Source Sun Yat-sen University
Contact Peirong Ding, M.D.
Phone 00862087343124
Email dingpr@sysucc.org.cn
Status Not yet recruiting
Phase Phase 2
Start date February 2023
Completion date January 2026

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