Fuquinitinib Combined With Cardonilizumab and SBRT Versus Fuquinitinib in Third-line and Post-line Treatment of Metastatic Colorectal Cancer: a Randomized, Controlled, Open, Multicenter Clinical Study
An assessment of 6-month progression-free survival in patients with mCRC with third-line and postline metastatic colorectal cancer in combination with cardonilizumab and fuquinitinib and SBRT compared with fuquinitinib monotherapy
• 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 s 2.5 times the upper limit of normal (ULN), Serum bilirubin s 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