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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Immunotherapy; Targeted Therapy; SBRT; TACE; HCC - Hepatocellular Carcinoma

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • NanFang Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with intermediate to advanced hepatocellular carcinoma (HCC) who received sequential TACE-SBRT followed by targeted immunotherapy at a single tertiary medical center. Eligible participants were adults (≥18 years) with unresectable disease not suitable for curative surgery or liver transplantation, with preserved liver function and measurable lesions. The population represents a hospital-based cohort identified from medical records rather than a community sample.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Sequential TACE-SBRT With Targeted Immunotherapy Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) according to mRECIST	Objective response rate (complete response + partial response) assessed by mRECIST based on imaging evaluation.	At baseline and every 3 months after treatment initiation, up to study completion (an average of 6months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		From treatment initiation until death from any cause, up to study completion (an average of 26 months)
Progression-Free Survival (PFS) according to mRECIST	Time from treatment initiation to disease progression or death, assessed by mRECIST.	From treatment initiation until disease progression or death, whichever occurs first, up to study completion (an average of 15 months)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0		From treatment initiation through study completion, up to 18 months

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: September 27, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• 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: NFEC-2025-159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No