A study to evaluate the adjuvant pattern in resected intermediate-stage hepatocellular carcinoma
| ISRCTN | ISRCTN12249513 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12249513 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2024-189, 81770566, 82400708, 2023YFS0229, 2025ZNSFSC1683, 2024HXBH112 |
| Sponsor | West China Hospital of Sichuan University |
| Funders | National Natural Science Foundation of China, Sichuan Provincial Science and Technology Support Program, West China Hospital, Sichuan University |
- Submission date
- 24/03/2025
- Registration date
- 16/06/2025
- Last edited
- 11/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Intermediate-stage hepatocellular carcinoma (HCC) following curative liver resection (LR) is associated with high recurrence rates and poor survival outcomes. This study evaluates the benefit of transarterial chemoembolization (TACE) combined with Lenvatinib plus programmed death-1 inhibitors (TAP) as an adjuvant treatment for resected intermediate-stage HCC compared to TACE alone. This study aims to (1) compare the efficacy of TACE-Lenvatinib-Programmed Death-1 inhibitors (TAP) versus TACE alone as adjuvant therapy for resected intermediate-stage HCC, and (2) identify subgroups most likely to benefit from TAP using predictive risk modeling.
Who can participate?
Patients with intermediate-stage HCC who underwent LR
What does the study involve?
Data were collected from the medical records of patients with intermediate-stage HCC who underwent LR. Overall survival (OS) and disease-free survival (DFS) were compared between patients with TACE and TAP using propensity score matching. Subgroup analyses were performed to present the intervention effects. The 2-year recurrence rate in the entire cohort was predicted based on the TACE group, and the interaction between the predicted DFS risk and observed DFS was tested.
What are the possible benefits and risks of participating?
No benefits or risks provided at registration
Where is the study run from?
West China Hospital, Sichuan University, China
When is the study starting and how long is it expected to run for?
January 2024 to October 2025
Who is funding the study?
1. The National Natural Science Foundation of China
2. The Sichuan Science and Technology Program
3. Postdoctoral Research Fund of West China Hospital, Sichuan University
Who is the main contact?
Guanhua Chen, 2839674774@qq.com
Contact information
Public, Scientific, Principal investigator
West China Hospital of Sichuan University
Chengdu City, Sichuan Province
610041
China
| Phone | +86 19960597910 |
|---|---|
| G.H.Chen769@look.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre retrospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Triple adjuvant therapy with TACE, lenvatinib, and PD-1 inhibitors improves short-term recurrence control in high-risk patients with resected intermediate-stage hepatocellular carcinoma |
| Study acronym | TAP-RISHCC |
| Study objectives | Transarterial chemoembolization combined with antiangiogenic therapy (lenvatinib) plus programmed death-1 inhibitors (TAP) shows better overall survival and disease-free survival in intermediate-stage HCC. Primary objective: A single-centre retrospective cohort study to evaluate the Benefit of Transarterial Chemoembolization (TACE) combined with antiangiogenic therapy (Lenvatinib) plus Programmed Death-1 Inhibitors (TAP) as an Adjuvant Treatment for resected Intermediate-Stage Hepatocellular Carcinoma. Secondary objectives: 1. To evaluate the benefit of the combination of TACE and Lenvatinib plus different programmed death-1 inhibitors in resected Intermediate-Stage Hepatocellular Carcinoma 2. Subgroup analysis to evaluate the response to TAP pattern in resected Intermediate-Stage Hepatocellular Carcinoma 3. Comparison of the effectiveness of TACE and TAP on tumor recurrence 4. Evaluate the safety of the TAP therapy |
| Ethics approval(s) |
Approved 10/01/2024, Biomedical Ethics Review Committee of the West China Hospital, Sichuan University (No.37, Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, 610000, China; +86 28 8542 2581; hxlcyjglb@163.com), ref: 20140110189 |
| Health condition(s) or problem(s) studied | Adjuvant therapy in intermediate-stage hepatocellular carcinoma |
| Intervention | This single-centre retrospective cohort study aims to evaluate the effectiveness of TACE combined with Lenvatinib plus Programmed Death-1 Inhibitors therapy in patients with intermediate-stage HCC who underwent liver resection compared to TACE alone Control group: TACE group Description: Patients who underwent liver resection receive TACE after 4-6 weeks when the liver function has recovered. Intervention group: TACE+ Lenvatinib+ Programmed Death-1 Inhibitors (drug) Description: Patients who underwent liver resection receive an adjuvant regimen involving TACE, Lenvatinib and Programmed Death-1 Inhibitors. The programmed Death-1 Inhibitors include Sintilimab, Camrelizumab, Tislelizumab and Pembrolizumab. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lenvatinib, sintilimab, camrelizumab, tislelizumab, pembrolizumab |
| Primary outcome measure(s) |
Disease-Free Survival (RFS), defined as the time from the date of curative resection to the date at which HCC recurred, measured using retrospective patient data at one timepoint |
| Key secondary outcome measure(s) |
The following secondary outcome measures were assessed using retrospective patient data at one timepoint: |
| Completion date | 03/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 560 |
| Total final enrolment | 571 |
| Key inclusion criteria | 1. Patients with intermediate-stage HCC undergoing curative LR. 2. Patients who received TACE alone or Lenvatinib+ PD-1 inhibitors +TACE 3. Child-Pugh class A or B that could improve to class A after treatment |
| Key exclusion criteria | 1. Patients who received any other adjuvant protocols 2. Without complete clinical data 3. Lost to Follow-up 4. Patients who died within three months post-surgery 5. A history of other malignancies or recurrent HCC. |
| Date of first enrolment | 08/05/2024 |
| Date of final enrolment | 02/10/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Chengdu, Sichuan Province
610000
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated will be available upon request from Guanhua Chen, G.H.Chen769@outloom.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/03/2025: Study'sexistence confirmed by the Biomedical Ethics Review Committee of the West China Hospital, Sichuan University.
