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Active, Not Recruiting

NCT Number: NCT07230080

Sequential TACE-SBRT Combined With Targeted Immunotherapy for Patients With Intermediate to Advanced Liver Cancer

The goal of this clinical trial is to evaluate whether sequential transarterial chemoembolization (TACE) followed by stereotactic body radiotherapy (SBRT) combined with targeted immunotherapy is effective and safe for patients with intermediate to advanced hepatocellular carcinoma (HCC) who are not eligible for curative treatment such as surgery or liver transplantation.

This is a single-center, single-arm, retrospective study. All participants included in the analysis will have received the combined treatment regimen.

The main question the study aims to answer is:

Can sequential TACE-SBRT combined with targeted immunotherapy improve the objective response rate (ORR) in patients with intermediate to advanced HCC?

Interventions

Participants in this study have undergone the following treatments:

TACE: a minimally invasive procedure to block the blood supply to the tumor while delivering chemotherapy directly.

SBRT: a highly precise form of radiation therapy targeting the liver tumor. Targeted immunotherapy: systemic treatment that stimulates the immune system to recognize and attack cancer cells.

Participant Population The study includes adult patients diagnosed with intermediate to advanced HCC who were not candidates for curative resection or transplantation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Immunotherapy Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial SBRT TACE Targeted Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hosptial

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Unresectable hepatocellular carcinoma (HCC)
  • CNLC stage IIb-IIIb
  • Target lesion(s) not previously treated with local therapy
  • Child-Pugh class A5-B7 liver function
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
  • At least one measurable lesion based on modified RECIST (mRECIST) criteria

Exclusion criteria

  • Diagnosis of any malignant disease other than primary liver cancer within 3 years prior to enrollment
  • Currently participating in another interventional clinical study
  • History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
  • Presence of any severe or uncontrolled systemic disease
  • Any medical history, comorbid condition, treatment, or abnormal laboratory finding that may interfere with study results or hinder full participation, or any other situation that the investigator considers inappropriate for enrollment
  • Investigator's judgment of other potential risks making the patient unsuitable for participation in this study

Treatment and study plan

Primary outcomes

  1. Objective Response Rate (ORR) according to mRECIST

    Time frame: At baseline and every 3 months after treatment initiation, up to study completion (an average of 6months)

    Objective response rate (complete response + partial response) assessed by mRECIST based on imaging evaluation.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From treatment initiation until death from any cause, up to study completion (an average of 26 months)

  2. Progression-Free Survival (PFS) according to mRECIST

    Time frame: From treatment initiation until disease progression or death, whichever occurs first, up to study completion (an average of 15 months)

    Time from treatment initiation to disease progression or death, assessed by mRECIST.

  3. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: From treatment initiation through study completion, up to 18 months

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Efficacy and Safety of Sequential TACE-SBRT Combined With Targeted Immunotherapy in Patients With Intermediate to Advanced Hepatocellular Carcinoma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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