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

Nanfang Hospital, Southern Medical University

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT07230080

NFEC-2025-159

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 1 patient group

Sequential TACE-SBRT With Targeted Immunotherapy Group