Neoplasms

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Carcinoma, Hepatocellular

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Gastrointestinal Diseases

Liver Diseases

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Bevacizumab

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TACE Combined With Bevacizumab Biosimilar

TACE + Bevacizumab (15mg/kg, intra-arterial infusion, Q3W) for 4 cycles, followed by maintenance therapy with Bevacizumab (15mg/kg, intravenously, Q3W) to a maximum total cycle of 18 unless any evidence of disease progression or unacceptable side effects.

Bevacizumab Biosimilar QL 1101

Fei Gao, Ph.D., M.D.

Han Qi, M.D.

The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with anti-VEGF (Bevacizumab Biosimilar) in patients with BCLC-B stage hepatocellular carcinoma beyond up-to-seven criteria.

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of TACE combined with anti-VEGF (Bevacizumab Biosimilar) in patients with BCLC-B stage hepatocellular carcinoma beyond up-to-seven criteria. Subjects who meet the admission criteria will be treated with Bevacizumab Biosimilar after TACE until disease progression, intolerable toxicity, death, patient withdrawal or the investigators determine that the drug must be discontinued.

The primary outcome is the objective response rate (ORR). The secondary outcomes include the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS). This study also aims to assess the safety and adverse events of TACE combined with anti-VEGF (Bevacizumab Biosimilar) for HCC (BCLC-B stage) beyond up-to-seven criteria.

TACE Combined With Bevacizumab in HCC (BCLC-B) Beyond Up-To-Seven Criteria

TACE Combined With Bevacizumab in Patients With BCLC-B Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria: a Prospective Single-arm Phase II Study

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST.

DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST.

The progression-free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIS.

ase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

Spots Global Cancer Trial Database for beyond up to seven criteria