A Phase Ib/II Clinical Study Evaluating TQB2922 for Injection and Chemotherapy in Combination With or Without Bevacizumab in Subjects With RAS/BRAF Wild-Type Advanced Colorectal Cancer Who Have Failed Chemotherapy
This is a multicenter, open Phase Ib/II clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS/BRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan.
• Subjects voluntarily enrolled in the study, signed the informed consent and had good compliance;
• Age: 18-75 years old (including boundaries at the time of signing the informed consent);
• Eastern Cooperative Oncology Group (ECOG) score: 0-1;
• Expected survival of more than 3 months;
• Unresectable locally advanced or metastatic colorectal cancer diagnosed by histological/cytological pathology;
• Disease progression or intolerable after prior treatment with oxaliplatin, fluorouracil-based and irinotecan and treated with cetuximab or bevacizumab;
• Patients with genetic testing showing wild-type for both rat sarcoma (RAS) and B-type rapid response protein kinase (BRAF);
• Presence of at least 1 measurable lesion according to RECIST 1.1 criteria;
• Laboratory tests meet the criteria;
• Female subjects of childbearing potential must agree to use contraception (e.g., Intrauterine Device (IUD), birth control pills, or condoms) for the duration of the study and for 6 months after the end of the study; must have a negative serum pregnancy/urine pregnancy test
• within 7 days prior to study entry and must not be breastfeeding; male subjects must agree to use contraception for the duration of the study and for 6 months after the end of the study.