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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
combinational treatment of Tislelizumab and Fruquintinib until PD, intolerable toxicity, death or withdrawal of informed consent
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
Xiaoshi Zhang
Guangzhou, China
Objective Response Rate (ORR)
The proportion of patients with a confirmed complete response or partial response
Time frame: up to 3 years
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Time frame: up to 3 years
Overall Survival (OS)
OS is defined as the time from enrollment to death due to any cause.
Time frame: up to 3 years
Disease control rate
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD).
Time frame: up to 3 years
Incidence of Treatment-Emergent Adverse Events
Safety and tolerance evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Time frame: until 60 days after last patient last study drug treatment
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