HCC - Hepatocellular CarcinomaNCT07230080
Sequential TACE-SBRT Combined With Targeted Immunotherapy for Patients With Intermediate to Advanced Liver Cancer
An observational study of HCC - Hepatocellular Carcinoma and SBRT, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, SBRT, TACE
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sequential TACE-SBRT With Targeted Immunotherapy Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) according to mRECIST
Objective response rate (complete response + partial response) assessed by mRECIST based on imaging evaluation.
Measured: At baseline and every 3 months after treatment initiation, up to study completion (an average of 6months)
Secondary outcomes (3)
Overall Survival (OS)
Measured: 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.
Measured: 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
Measured: From treatment initiation through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Sep 2024
- Primary completion20 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230080
- Sponsor's protocol ID
- NFEC-2025-159
- Status last verified
- Nov 2025
- First submitted
- 27 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sequential TACE-SBRT Combined With Targeted Immunotherapy in Patients With Intermediate to Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07230080
- Acronym / sponsor ID
- NFEC-2025-159
- Conditions
- HCC - Hepatocellular Carcinoma, SBRT, TACE, Immunotherapy, Targeted Therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential TACE-SBRT With Targeted Immunotherapy Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective Response Rate (ORR) according to mRECIST
Time frame: 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.
3 secondary outcomes
Overall Survival (OS)
Time frame: 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 frame: 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
Time frame: From treatment initiation through study completion, up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma and SBRT, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) according to mRECIST (time frame: At baseline and every 3 months after treatment initiation, up to study completion (an average of 6months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.