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

NCT06199297 | Completed

• 1 other identifier: B2023-690-01
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• objective response rate，ORR

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

  24 months

• 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 Outcomes (2)

• treatment-related adverse events, TRAEs

  24 months

• overall survival, OS

  24 months

Study Arms (2)

ABTH

Atezolizumab plus bevacizumab combined with TACE-HAIC

Drug: Atezolizumab combined with Bevacizumab; Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

SBTH

Sintilimab plus bevacizumab combined with TACE-HAIC

Drug: Sintilimab combined with Bevacizumab; Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy

Interventions

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

ABTH

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

SBTH

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.

ABTH; SBTH

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This retrospective real-world study enrolled patients treated in three medical centers in China, including Sun Yat-sen University Cancer Center, Affiliated Cancer Hospital \& Institute of Guangzhou Medical University, and Sun Yat-Sen Memorial Hospital. These patients, diagnosed with treatment-naive uHCC, underwent simultaneous combination TACE-HAIC and A+B or S+B.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Wei He

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: March 2, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)