TACE With Immune Agents for Angiogenesis in Hepatocellular Carcinoma

NCT07053202 | Completed DMC

• 1 other identifier: 2021-B-035
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the clinical efficacy and safety of transarterial chemoembolization (TACE) combined with the immune agent nivolumab compared to TACE alone for treating hepatocellular carcinoma (HCC). The study aims to determine if the combination therapy can more effectively inhibit tumor angiogenesis, improve clinical benefit rates, and prolong survival, while maintaining a high safety profile.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

TACE; Immune agents; Hepatic arterial infusion; Hepatocellular carcinoma; Tumor angiogenesis; Nivolumab

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  Percentage of patients achieving Complete Remission (CR) or Partial Remission (PR) based on RECIST 1.1 criteria. ORR = \[(CR + PR) / total cases\] × 100%.

  Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.

• Disease Control Rate (DCR)

  Percentage of patients achieving CR, PR, or Stable Disease (SD) based on RECIST 1.1 criteria. DCR = \[(CR + PR + SD) / total cases\] × 100%.

  Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.

Secondary Outcomes (9)

• Level of Vascular Endothelial Growth Factor (VEGF)

  Baseline (one day before treatment) and 1 month after treatment.

• Level of VEGF Receptor-2 (VEGFR-2)

  Baseline (one day before treatment) and 1 month after treatment.

• Level of Angiopoietin-2 (Ang-2)

  Baseline (one day before treatment) and 1 month after treatment.

• Level of Carcinoembryonic Antigen (CEA)

  Baseline (one day before treatment) and 1 month after treatment.

• Level of Alpha-fetoprotein (AFP)

  Baseline (one day before treatment) and 1 month after treatment.

Study Arms (2)

TACE combined with Nivolumab

EXPERIMENTAL

Patients received TACE procedure. Additionally, hepatic artery infusion therapy with nivolumab was performed.

Combination Product: Nivolumab; Procedure: Transarterial Chemoembolization (TACE)

TACE Alone

ACTIVE COMPARATOR

Patients received TACE procedure alone.

Procedure: Transarterial Chemoembolization (TACE)

Interventions

Nivolumab COMBINATION_PRODUCT

hepatic artery infusion therapy with nivolumab was performed

TACE combined with Nivolumab

Transarterial Chemoembolization (TACE) PROCEDURE

Seldinger technique for femoral artery puncture. Catheterization to celiac trunk/hepatic artery. Infusion of a mixture of idarubicin, raltitrexed, iodized oil, and contrast agent (approx. 8 mL). Embolization with microspheres (300-500 μm and 500-700 μm).

TACE Alone; TACE combined with Nivolumab

Eligibility Criteria

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

You may qualify if:

• Age \>18 years;
• Diagnosis of HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition), confirmed by pathological examination;
• Barcelona Clinic Liver Cancer (BCLC) stages A, B, and C, with non-resectable tumors;
• Liver function graded as Child-Pugh A or B;
• At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• No severe hematologic abnormalities or immune deficiencies;
• Expected survival time \>6 months.

You may not qualify if:

• Recurrent liver cancer or metastatic cancer from other organs;
• Previous treatment with other antitumor therapies, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy;
• History of other malignant tumors;
• Pregnant or lactating women;
• Human immunodeficiency virus (HIV) infection;
• Severe cardiovascular, pulmonary, cerebral, or renal diseases;
• Active bleeding or coagulopathy outside the liver;
• Enrollment in another clinical trial or participation in a clinical trial within one month prior to admission;
• Psychiatric disorders or unstable mental status;
• Allergic reactions to the study drugs;
• Severe gastrointestinal diseases, such as active ulcers, or other conditions affecting drug absorption.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Nivolumab

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 Officials

• Wenhua Ma

  Department of Oncology, The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 8, 2025
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 31, 2023
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

CN (1)