Hepatocellular Carcinoma (HCC)NCT07658833
TACE and/or HAIC Combined With Molecular-targeted Therapy and Immunotherapy for HCC
An observational study of Hepatocellular Carcinoma (HCC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and/or hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- TACE (transarterial chemoembolization) combined with targeted/immunotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 HCC patients who underwent TACE and/or HAIC combined with molecular-targeted therapy and immunotherapy between January 2021 and December 2025 were enrolled.
Who may be able to join
- aged 18-80 years
- Eastern Cooperative Oncology Group (ECOG) performance status score < 2
- maximum tumor diameter ≥ 7 cm
- IVC/RA TT diagnosed by contrast-enhanced CT / MRI before study treatment
- unresectable HCC (uHCC) confirmed by a specialized multidisciplinary team
- liver function of Child-Pugh class A or B
Who cannot join
- with other malignancies
- prior anti-tumor therapy
- history of drug allergy
- autoimmune diseases
- digestive hemorrhage of any grade
- insufficient renal, bone marrow, or coagulation function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiayan Ni
Guangzhou, None Selected, 510120
Jiayan Ni, MD., 02034070680, jiayan_0129@126.com
About this study
Official title: Study of the Safety, Clinical Efficacy and Prognostic Factors of TACE and/or HAIC Combined With Molecular-targeted Therapy and Immunotherapy for Hepatocellular Carcinoma
The safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and/or hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. This research aims to evaluate the safety, clinical efficacy and prognostic factors of TACE and/or HAIC combined with targeted immunotherapy for hepatocellular carcinoma.
We are going to compare and analyze local tumor response, survival outcomes, prognostic factors and adverse events. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This study intends to include the targeted and immunotherapy applied, mainly including: lenvatinib, sorafenib, apatinib, bevacizumab, etc.; pembrolizumab, carfilzomib, sintilimab and teprotumumab, etc.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- TACE (transarterial chemoembolization) combined with targeted/immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE (transarterial chemoembolization) combined with targeted/immunotherapyProcedure or surgery
transarterial chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| TACE-HAIC-MTT-PD-1i | Not described Receives: Procedure: TACE (transarterial chemoembolization) combined with targeted/immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
OS was calculated as the duration from the date of the first cycle of the study combination therapy to the date of death or last date of follow-up.
Measured: 1-, 2-, 3-, and 5-year
Secondary outcomes (1)
Progression-free survival (PFS)
PFS was defined as the duration from the date of the first cycle of the combination therapy to tumor lesion progression, death, or last follow-up, whichever came first.
Measured: 1-, 2-, and 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658833
- Sponsor's protocol ID
- SYSKY-2025-1049-01
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety, Clinical Efficacy and Prognostic Factors of TACE and/or HAIC Combined With Molecular-targeted Therapy and Immunotherapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07658833
- Acronym / sponsor ID
- SYSKY-2025-1049-01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 Jun 2026 (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 safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and/or hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. This research aims to evaluate the safety, clinical efficacy and prognostic factors of TACE and/or HAIC combined with targeted immunotherapy for hepatocellular carcinoma.
We are going to compare and analyze local tumor response, survival outcomes, prognostic factors and adverse events. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This study intends to include the targeted and immunotherapy applied, mainly including: lenvatinib, sorafenib, apatinib, bevacizumab, etc.; pembrolizumab, carfilzomib, sintilimab and teprotumumab, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE-HAIC-MTT-PD-1i | – | Procedure: TACE (transarterial chemoembolization) combined with targeted/immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 HCC patients who underwent TACE and/or HAIC combined with molecular-targeted therapy and immunotherapy between January 2021 and December 2025 were enrolled.
Key inclusion criteria (6 listed)
- aged 18-80 years
- Eastern Cooperative Oncology Group (ECOG) performance status score < 2
- maximum tumor diameter ≥ 7 cm
- IVC/RA TT diagnosed by contrast-enhanced CT / MRI before study treatment
- unresectable HCC (uHCC) confirmed by a specialized multidisciplinary team
Key exclusion criteria (6 listed)
- with other malignancies
- prior anti-tumor therapy
- history of drug allergy
- autoimmune diseases
- digestive hemorrhage of any grade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE (transarterial chemoembolization) combined with targeted/immunotherapytransarterial chemoembolization | Procedure or surgery | TACE-HAIC-MTT-PD-1i |
Primary outcome
Overall survival(OS)
Time frame: 1-, 2-, 3-, and 5-year
OS was calculated as the duration from the date of the first cycle of the study combination therapy to the date of death or last date of follow-up.
1 secondary outcome
Progression-free survival (PFS)
Time frame: 1-, 2-, and 3-year
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 22 Jun 2026.
- 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.
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 Hepatocellular Carcinoma (HCC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 6 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival(OS) (time frame: 1-, 2-, 3-, and 5-year). 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 22 Jun 2026.