A Phase II, Single-arm, Open-label, Multi-Centers Study of Cadonilimab Combined With Fruquintinib and SBRT as A Third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer
A Phase II Study to Assess the Efficacy and Safety of Cadonilimab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer
• Provision of written Informed Consent Form (ICF) prior to any study specific procedures
• Age ≥ 18 years, ≤75 years
• Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer
• MSI status: MSS
• At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities
• ECOG 0-1
• Patients must have measurable lesions
• Expected overall survival ≥12 weeks
• AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine\<ULN
• Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
• Patients are allowed to have received radiotherapy, but the time from entering the group must be more than 4 weeks, and the currently selected radiotherapy lesions and evaluable lesions must be lesions that have not received radiotherapy
• Fertile male or female patients voluntarily used an effective contraceptive method during the study period and within 6 months of the last study medication