Hepatocellular Carcinoma Clinical Trial
Official title:
Sun Yat-sen University Cancer Center
The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with pd-1 antibody immunotherapy (Sintilimab) and anti-VEGF (Bevacizumab Biosimilar) in patients with advanced hepatocellular carcinoma (BCLC-C Stage).
This is a prospective, single arm, phase II study to evaluate the efficacy and safety of TACE combined with Sintilimab and Bevacizumab Biosimilar (T-Double Therapy) in patients with HCC (BCLC-C Stage). Subjects who meet the admission criteria will be treated with Sintilimab and Bevacizumab Biosimilar after TACE until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued. The primary outcome measure is to evaluate the objective response rate (ORR) of T-Double Therapy for advanced HCC (BCLC C-stage). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) in 6- and 12-months, overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS) of T-Double Therapy for advanced HCC. This study also aims to assess the safety and adverse reactions of T-Double Therapy for advanced HCC. ;
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