Hepatocellular Carcinoma (HCC)HCCNCT07562763
Estimation and Prediction of Individual Benefit From Postoperative Adjuvant Transcatheter Arterial Chemoembolization For Patients With Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma (HCC) and Transarterial Chemoembolization, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Adjuvant transarterial chemoembolization (TACE) is widely adopted in China for resectable hepatocellular carcinoma (HCC), yet its efficacy remains inconsistent. We aimed to identify factors influencing individual patient benefit using causal machine learning. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Transarterial Chemoembolization, Adjuvant Therapy
- How many people
- 1,005 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients with high-risk factors of tumor relapse, who received adjuvant TACE or active postoperative survelliance as treatment.
Who may be able to join
- (1) pathologic diagnosis of HCC; (2) received potentially curative hepatectomy with negative cut margins confirmed by pathology; (3) high risk of recurrence, meeting any of the following criteria: largest tumor >5 cm, multiple lesions, poor histological differentiation (Edmondson-Steiner grade III or IV), presence of microvascular invasion or satellite nodules, (4) received adjuvant TACE or active surveillance as postoperative treatment; (5) at least one year of follow-up.
Who cannot join
- (1) history of other malignancies; (2) received preoperative anti-tumor treatment; (3) presence of vascular invasion or extrahepatic metastasis; (4) tumor recurred within 4 weeks postoperatively; (5) residual tumor was detected by digital subtraction angiography (DSA); (6) received other types of adjuvant therapy; (7) cases with missing data exceeding 10%.
Trial locations and contacts
1 site in 1 country.
About this study
Adjuvant transarterial chemoembolization (TACE) is widely adopted in China for resectable hepatocellular carcinoma (HCC), yet its efficacy remains inconsistent. We aimed to identify factors influencing individual patient benefit using causal machine learning. To this end, we retrospectively collected HCC patients with high risk factors for tumor recurrence from four centers of China, divided into the discovery cohort and the validation cohort . The primary endpoint was disease-free survival (DFS). The primary endpoint was overall survival (OS).Individual treatment effects (ITEs) were estimated within a causal machine learning framework. An ITE < 0 was considered recommendation for adjuvant TACE , while ITE ≥ 0 indicated active surveillance. The model would be validated in the validation cohort. The contribution of each variable to ITE was assessed using the Shapley Additive Explanations (SHAP). An online calculator would be developed for future use by public.
- Conditions
- Hepatocellular Carcinoma (HCC), Transarterial Chemoembolization, Adjuvant Therapy, Machine Learning, Treatment Effectiveness
- 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 |
|---|---|---|
| Discovery cohort | The cohort is used for training of the causal machine learning model | |
| Validation cohort | The cohort is used for validation of the causal machine learning model | |
| Adjuvant Tace Group | Patients who received adjuvant TACE as postoperative treatment | |
| Active Surveillance Group | Patients who received active surveillance as postoperative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease-free survival (DFS) was defined as the time from the date of curative-intent HCC surgery to the first occurrence of local recurrence, distant metastasis, or death from any cause, whichever came first. Patients without any of these events were censored at the last follow-up.
Measured: From January 2018 to December 2023
Secondary outcomes (1)
Overall survival
Overall Survival (OS) was defined as the time from the date of curative-intent HCC surgery to the first occurrence of death from any cause. Patients who were still alive at the last follow-up were censored at the date of the last follow-up.
Measured: From January 2018 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jan 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Sun Yat-Sen University Cancer Center, No.2 People's Hospital of Fuyang City, Affiliated Hospital of Qinghai University, Anhui Provincial Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Lianxin Liu, Ph.D., Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562763
- Sponsor's protocol ID
- PA-TACE-ITE
- Acronym
- HCC
- Status last verified
- Jul 2026
- First submitted
- 26 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patients' privacy
Publications
Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.
PubMed 29420221Wei W, Jian PE, Li SH, Guo ZX, Zhang YF, Ling YH, Lin XJ, Xu L, Shi M, Zheng L, Chen MS, Guo RP. Adjuvant transcatheter arterial chemoembolization after curative resection for hepatocellular carcinoma patients with solitary tumor and microvascular invasion: a randomized clinical trial of efficacy and safety. Cancer Commun (Lond). 2018 Oct 10;38(1):61. doi: 10.1186/s40880-018-0331-y.
PubMed 30305149Ma T, Bai X, Zhang Q, Chen W, Huang K, Qian T, Xu Y, Sun P, Chen Y, Xiao W, Sun K, Gao S, Liang T. Adjuvant transarterial chemoembolization for hepatocellular carcinoma following curative resection: A randomized, open-label, phase 3 trial. Hepatology. 2025 Nov 1;82(5):1112-1121. doi: 10.1097/HEP.0000000000001233. Epub 2025 Jan 14.
PubMed 39808820
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation and Prediction of Individual Benefit From Postoperative Adjuvant Transcatheter Arterial Chemoembolization For Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07562763
- Acronym / sponsor ID
- HCC / PA-TACE-ITE
- Conditions
- Hepatocellular Carcinoma (HCC), Transarterial Chemoembolization, Adjuvant Therapy, Machine Learning, Treatment Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Sun Yat-Sen University Cancer Center, No.2 People's Hospital of Fuyang City, Affiliated Hospital of Qinghai University, Anhui Provincial Cancer Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 May 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.
Adjuvant transarterial chemoembolization (TACE) is widely adopted in China for resectable hepatocellular carcinoma (HCC), yet its efficacy remains inconsistent. We aimed to identify factors influencing individual patient benefit using causal machine learning. To this end, we retrospectively collected HCC patients with high risk factors for tumor recurrence from four centers of China, divided into the discovery cohort and the validation cohort . The primary endpoint was disease-free survival (DFS). The primary endpoint was overall survival (OS).Individual treatment effects (ITEs) were estimated within a causal machine learning framework. An ITE < 0 was considered recommendation for adjuvant TACE , while ITE ≥ 0 indicated active surveillance. The model would be validated in the validation cohort. The contribution of each variable to ITE was assessed using the Shapley Additive Explanations (SHAP). An online calculator would be developed for future use by public.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Discovery cohort | – | –The cohort is used for training of the causal machine learning model |
| Validation cohort | – | –The cohort is used for validation of the causal machine learning model |
| Adjuvant Tace Group | – | –Patients who received adjuvant TACE as postoperative treatment |
| Active Surveillance Group | – | –Patients who received active surveillance as postoperative treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients with high-risk factors of tumor relapse, who received adjuvant TACE or active postoperative survelliance as treatment.
Key inclusion criteria (1 listed)
- (1) pathologic diagnosis of HCC; (2) received potentially curative hepatectomy with negative cut margins confirmed by pathology; (3) high risk of recurrence, meeting any of the following criteria: largest tumor >5 cm, multiple lesions, poor histological differentiation (Edmondson-Steiner grade III or IV), presence of microvascular invasion or satellite nodules, (4) received adjuvant TACE or active surveillance as postoperative treatment; (5) at least one year of follow-up.
Key exclusion criteria (1 listed)
- (1) history of other malignancies; (2) received preoperative anti-tumor treatment; (3) presence of vascular invasion or extrahepatic metastasis; (4) tumor recurred within 4 weeks postoperatively; (5) residual tumor was detected by digital subtraction angiography (DSA); (6) received other types of adjuvant therapy; (7) cases with missing data exceeding 10%.
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
Disease free survival
Time frame: From January 2018 to December 2023
Disease-free survival (DFS) was defined as the time from the date of curative-intent HCC surgery to the first occurrence of local recurrence, distant metastasis, or death from any cause, whichever came first. Patients without any of these events were censored at the last follow-up.
1 secondary outcome
Overall survival
Time frame: From January 2018 to December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 29420221Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.
- Background: PubMed 30305149Wei W, Jian PE, Li SH, Guo ZX, Zhang YF, Ling YH, Lin XJ, Xu L, Shi M, Zheng L, Chen MS, Guo RP. Adjuvant transcatheter arterial chemoembolization after curative resection for hepatocellular carcinoma patients with solitary tumor and microvascular invasion: a randomized clinical trial of efficacy and safety. Cancer Commun (Lond). 2018 Oct 10;38(1):61. doi: 10.1186/s40880-018-0331-y.
- Background: PubMed 39808820Ma T, Bai X, Zhang Q, Chen W, Huang K, Qian T, Xu Y, Sun P, Chen Y, Xiao W, Sun K, Gao S, Liang T. Adjuvant transarterial chemoembolization for hepatocellular carcinoma following curative resection: A randomized, open-label, phase 3 trial. Hepatology. 2025 Nov 1;82(5):1112-1121. doi: 10.1097/HEP.0000000000001233. Epub 2025 Jan 14.
- Individual participant dataSharing planned: No. For patients' privacy
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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.
Lianxin Liu, Ph.D. principal investigator
The First Affiliated Hospital of University of Science and Technology of China
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) and Transarterial Chemoembolization, run by Anhui Provincial Hospital 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 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: finished, as of the sponsor's last update on 9 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease free survival (time frame: From January 2018 to December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07562763, which also lists 3 linked publications.
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 9 Jul 2026.