Hepatocellular Carcinoma (HCC)NCT07156617
A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data
An observational study of Hepatocellular Carcinoma (HCC), run by Xuhua Duan at 14 sites in China.
Trial summary
The system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Interventional therapy and Systemic therapy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 14 sitesChina
- Study dates
- 1 Oct 2025to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular carcinoma
Who may be able to join
- 1. Age ≥ 18 years old, gender not restricted; 2. Diagnosed with HCC through pathological or imaging examination, and meeting the diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)"; 3. Has received or plans to receive interventional therapy combined with systemic treatment (including but not limited to DEB-TACE combined with targeted therapy, DEB-TACE combined with targeted therapy and immunotherapy, DEB-TACE combined with targeted therapy and immunotherapy other local interventional treatments (such as HAIC, ablation, particle implantation, etc.)); 4. Has completed baseline clinical information and treatment records, can cooperate with the follow-up arrangement, and has the willingness and ability to complete the entire research process; 5. Signed the informed consent form.
Who cannot join
- 1. Diagnosed with liver metastatic cancer or other primary malignant tumors that are not HCC, or with concurrent other active primary malignant tumors; 2. Clearly have severe cognitive impairment, mental illness or confusion, and are unable to cooperate with the visit or fill out the scale; 3. Expected survival period is less than 3 months or clinical judgment indicates that follow-up cannot be completed; 4. Liver function is in decompensation, with Child-Pugh classification as C; 5. The investigator considers any other situation that is not suitable for participating in this study.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites
Deng zhou People's Hospital
Dengzhou, Henan
Yanliang Li
The Second Affiliated Hospital of Hainan Medical Universsity
Haikou, Hainan
Yong Wang
The Second People's Hospital of Jiaozuo
Jiaozuo, Henan
Chuntang Qin
Second People's Hospital of Jiaozuo
Jiaozuo
Chuntang Qin
Huai He Hospital of Henan University
Kaifeng, Henan
Xiang He
Luo Yang Central Hospital
Luoyang, Henan
Fazhong Li
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan
Huanzhang Niu, 18567635732, niuhuanzhang@126.com
Jiangxi Provincial People's Hospitail
Nanchang, Jiangxi
Shihua Luo
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
First People's Hospital of Shangqiu
Shangqiu, Henan
Zhenhua Tian
Wuxi No.5 People's Hospital
Wuxi, Jiangsu
Xingtai No.5 Hospital
Xingtai, Hebei
Menglong Li
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xuhua Duan, 13523402912, xuhuaduan@163.com
xuhuaduan@163.com
Zhou Kou Central Hospital
Zhoukou, Henan
Cheng Xing
About this study
The system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. It explores the clinical characteristics and biomarker levels of patients related to heterogeneity and builds a machine learning model to predict the risk of adverse reactions, providing evidence support for the construction of a patient-centered individualized decision-making system.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Interventional therapy, Systemic therapy
- Keywords
- Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional therapyProcedure or surgery
Interventional therapy
Systemic therapyDrug
Also called Targeted Therapy, Immunotherapy
Targeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab
| Study group | Role | What they receive |
|---|---|---|
| Interventional therapy combined with systemic therapy | Interventional therapy combined with systemic therapy is divided into three subgroups, including 1)DEB-TACE in Combination with Targeted Therapy；2） DEB-TACE in Combination with Targeted Therapy and Immunotherapy；3）DEB-TACE in Combination with Targeted Therapy, Immunotherapy, and Other Interventional Therapies. Receives: Procedure: Interventional therapy; Drug: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rwPFS
The definition of rwPFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.
Measured: up to 2 years
Secondary outcomes (5)
ORR
ORR is defined as the proportion of patients who achieve complete remission (CR, Complete Response) and partial remission (PR, Partial Response) according to the mRECIST criteria.
Measured: up to 2 years
rwOS
The rwOS is defined as the time from the first administration of combined therapy to the occurrence of any cause of death. If there is no death record for the patient, the last visit time will be used as the censored value.
Measured: up to2years
rwTTP
The rwTTP is defined as the time from the first administration of combined therapy to the first imaging assessment revealing tumor progression.
Measured: up to2years
PRO
The PRO score includes the scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its liver cancer module (EORTC QLQ-HCC18) that were filled out by the patients themselves.
Measured: up to2years
AE
Adverse Event
Measured: up to2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 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.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuhua Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuhua Duan, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156617
- Sponsor's protocol ID
- 2025-KY-1142-002
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data
- ClinicalTrials.gov ID
- NCT07156617
- Acronym / sponsor ID
- 2025-KY-1142-002
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xuhua DuanUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 5 Sep 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 system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. It explores the clinical characteristics and biomarker levels of patients related to heterogeneity and builds a machine learning model to predict the risk of adverse reactions, providing evidence support for the construction of a patient-centered individualized decision-making system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional therapy combined with systemic therapy | – | Procedure: Interventional therapy, Drug: Systemic therapyInterventional therapy combined with systemic therapy is divided into three subgroups, including 1)DEB-TACE in Combination with Targeted Therapy；2） DEB-TACE in Combination with Targeted Therapy and Immunotherapy；3）DEB-TACE in Combination with Targeted Therapy, Immunotherapy, and Other Interventional Therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular carcinoma
Key inclusion criteria (1 listed)
- 1. Age ≥ 18 years old, gender not restricted; 2. Diagnosed with HCC through pathological or imaging examination, and meeting the diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)"; 3. Has received or plans to receive interventional therapy combined with systemic treatment (including but not limited to DEB-TACE combined with targeted therapy, DEB-TACE combined with targeted therapy and immunotherapy, DEB-TACE combined with targeted therapy and immunotherapy other local interventional treatments (such as HAIC, ablation, particle implantation, etc.)); 4. Has completed baseline clinical information and treatment records, can cooperate with the follow-up arrangement, and has the willingness and ability to complete the entire research process; 5. Signed the informed consent form.
Key exclusion criteria (1 listed)
- 1. Diagnosed with liver metastatic cancer or other primary malignant tumors that are not HCC, or with concurrent other active primary malignant tumors; 2. Clearly have severe cognitive impairment, mental illness or confusion, and are unable to cooperate with the visit or fill out the scale; 3. Expected survival period is less than 3 months or clinical judgment indicates that follow-up cannot be completed; 4. Liver function is in decompensation, with Child-Pugh classification as C; 5. The investigator considers any other situation that is not suitable for participating in this study.
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 |
|---|---|---|
| Interventional therapyInterventional therapy | Procedure or surgery | Interventional therapy combined with systemic therapy |
| Systemic therapyAlso: Targeted Therapy, ImmunotherapyTargeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab | Drug | Interventional therapy combined with systemic therapy |
Primary outcome
rwPFS
Time frame: up to 2 years
The definition of rwPFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.
5 secondary outcomes
ORR
Time frame: up to 2 years
rwOS
Time frame: up to2years
rwTTP
Time frame: up to2years
PRO
Time frame: up to2years
AE
Time frame: up to2years
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 5 Sep 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.
14 sites 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 Xuhua Duan at 14 sites 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Contact Xuhua Duan (+8613523402912, xuhuaduan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rwPFS (time frame: up to 2 years). 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 5 Sep 2025.