Spots Global Cancer Trial Database for TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study

Study Description

Brief Summary: 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).

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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