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

NCT07230080 | Active Not Recruiting

• 1 other identifier: NFEC-2025-159
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HCC - Hepatocellular Carcinoma; SBRT; TACE; Immunotherapy; Targeted Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  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

Study Arms (1)

Sequential TACE-SBRT With Targeted Immunotherapy Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hosptial

Guangzhou, 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 Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: November 17, 2025
• Study Start: September 1, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 30, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)