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Active, not recruitingNCT07230080Updated Nov 17, 2025

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

An observational study in HCC - Hepatocellular Carcinoma, SBRT and TACE, sponsored by Nanfang Hospital, Southern Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • HCC - Hepatocellular Carcinoma
  • SBRT
  • TACE
  • Immunotherapy
  • Targeted Therapy
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 17 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • Sequential TACE-SBRT With Targeted Immunotherapy Group
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What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) according to mRECIST

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

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

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

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

  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

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Study locations

1 site
  • Nanfang Hosptial
    Guangzhou, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07230080
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Sep 1, 2024
Primary completion
Nov 20, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Nov 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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