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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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