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Active, not recruiting Observational

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

NCT07230080 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-09-01
Last updated
2025-11-17

Condition(s) studied

HCC - Hepatocellular CarcinomaSBRTTACEImmunotherapyTargeted Therapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective Response Rate (ORR) according to mRECIST — 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.

Trial sites (1)

FacilityCityRegionStatus
Nanfang Hosptial Guangzhou China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07230080 on ClinicalTrials.gov ↗ ← All trials in China