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

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

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

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma (HCC)

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. anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors 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,anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors, 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 anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors, ICIs, and TACE versus Lenvatinib combined with ICIs in advanced-stage HCC with vascular invasions

• Study Type: Observational
• Enrollment (Actual): 2651

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Zhongda hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with advanced HCC and macrovascular invasion who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions

Description

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of macrovascular invasion;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
7. Has repeated measurable intrahepatic lesions;

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival(OS)	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.	up to approximately 2 years
Progression free survival(PFS) according to per mRECIST or RECIST 1.1	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.	up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate(ORR) per RESCIST 1.1	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.	up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0	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.	up to approximately 2 years
ORR per mRECIST	The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST	up to approximately 2 years

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-jun Teng, M.D, Zhongda hospital, Southeast university, Nanjing, China

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; transarterial chemoembolization; immune checkpoint inhibitors; molecular target therapies
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: CHANCE2505

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No