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OpenTrials
Completed

NCT Number: NCT06199297

Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With TACE and HAIC in Unresectable Hepatocellular Carcinoma

Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wei He

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (a) a confirmed diagnosis of uHCC;
  • (b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria;
  • (c) Child-Pugh Grade A or B.

Exclusion criteria

  • (a) previous exposure to other anti-cancer treatments;
  • (b) diagnosis of any other primary malignancy;
  • (c) significant esophageal varices or observable red wale marks;
  • (d) a history of severe cardiac, pulmonary, or renal comorbidities;
  • (e) incomplete follow-up records.

Treatment and study plan

Atezolizumab combined with bevacizumab

Drug

Atezolizumab 1200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions

Sintilimab combined with Bevacizumab

Drug

Sintilimab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions

Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

Procedure

The chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h.

Primary outcomes

  1. objective response rate,ORR

    Time frame: 24 months

    Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1)

  2. progression free survival,PFS

    Time frame: 24 months

    Assessed using the mRECIST criteria, defined as patient survival without tumor progression from the start of randomization to the end of year 2

Secondary outcomes

  1. treatment-related adverse events, TRAEs

    Time frame: 24 months

    incidence rates of treatment-related adverse events during the study

  2. overall survival, OS

    Time frame: 24 months

    Defined as the time from the start of randomization to death from any cause

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multicenter Real-World Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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