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

Hepatocellular Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199297
• Other study ID #: B2023-690-01
• Status: Completed
• Start date: March 2, 2021
• Est. completion date: July 25, 2023

Study information

• Verified date: January 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Atezolizumab combined with Bevacizumab
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
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

Procedure:
• Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy
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.

Locations

Country	Name	City	State
China	Wei He	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate,ORR	Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1)	24 months
Primary	progression free survival,PFS	Assessed using the mRECIST criteria, defined as patient survival without tumor progression from the start of randomization to the end of year 2	24 months
Secondary	treatment-related adverse events, TRAEs	incidence rates of treatment-related adverse events during the study	24 months
Secondary	overall survival, OS	Defined as the time from the start of randomization to death from any cause	24 months