Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without HAIC for Unresectable HCC With Portal Vein Tumor Thrombosis

NCT06881433 | Completed

• 1 other identifier: CHANCE2504
• Study Type: observational
• Target: 1,649
• Locations: 1 country
• Sites: 1

Brief Summary

Anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors (VEGF/TKI-ICI) plus Immune checkpoint inhibitors (ICIs) are recommended for patients with unresectable hepatocellular carcinoma (HCC) with PVTT in China. However, these treatments have limited survival benefit in patients with advanced HCC with PVTT. We aimed to investigate whether hepatic arterial infusion chemotherapy (HAIC) in combination with VEGF/TKI-ICI and ICIs could improve the efficacy.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

hepatocellular carcinoma; immune checkpoint inhibitors; molecular target therapies; hepatic infusion chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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) per RECIST 1.1 or mRECIST

  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 mRECIST) or death due to any cause, whichever occurs first.

  up to approximately 2 years

Secondary Outcomes (3)

• Objective response rate(ORR) per RESCIST 1.1

  up to approximately 2 years

• ORR per mRECIST

  up to approximately 2 years

• Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0

  up to approximately 2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with unresectable HCC and PVTT who received HAIC in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Gao-jun Teng, M.D

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: June 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

CN (1)