Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without TACE for Advanced HCC with Vascular Invasions

Recruiting

• Conditions: Hepatocellular Carcinoma (HCC)

• Registration Number: NCT06881446
• Lead Sponsor: Zhongda Hospital

Brief Summary

Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma with vascular invasions

Detailed Description

The vascular invasions is a common complication in 16% to 30% of patients with hepatocellular carcinoma (HCC), contributing to poor prognosis and increasing the risk of cancer recurrence, with a median survival of approximately 2.7 to 4 months without intervention. Both the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases guidelines recommend that HCC patients with vascular invasions be classified as Barcelona Clinic Liver Cancer Stage C and receive systemic treatments. Nevertheless, there is limited data on patients with highly complicated HCC and no optimal treatment strategy for this patient population. Tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) are commonly utilized in the systemic therapy of HCC, while the combination of transcatheter arterial chemoembolization (TACE) with systemic therapy has significantly improved treatment outcomes in advanced-stage patients. Therefore, we hypothesized that a triplet regimen comprising TACE, TKI, and ICIs may yield better prognoses for HCC patients with vascular invasions. This study aims to compare the safety and efficacy of the triplet regimen of TKIs, ICIs, and TACE versus Lenvatinib combined with ICIs in advanced-stage HCC with vascular invasions

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
3. Child-Pugh C or PS>2 or Severe hepatic encephalopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	up to approximately 2 years	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Progression free survival(PFS) according to per mRECIST or RECIST 1.1	up to approximately 2 years	per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Description: The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.; PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Description: The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
ORR per mRECIST	up to approximately 2 years	The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST
Objective response rate(ORR) per RESCIST 1.1	up to approximately 2 years	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0	up to approximately 2 years	The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China