A study to evaluate the adjuvant pattern in resected intermediate-stage hepatocellular carcinoma

ISRCTN ISRCTN12249513
DOI https://doi.org/10.1186/ISRCTN12249513
Secondary identifying numbers 2024-189, 81770566, 82400708, 2023YFS0229, 2025ZNSFSC1683, 2024HXBH112
Submission date
24/03/2025
Registration date
16/06/2025
Last edited
11/06/2025
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Guanhua Chen
Public, Scientific, Principal Investigator

West China Hospital of Sichuan University
Chengdu City, Sichuan Province
610041
China

Phone +86 19960597910
Email G.H.Chen769@look.com

Study information

Study designSingle-centre retrospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Medical and other records
Study typeTreatment, Efficacy
Participant information sheet No participant information sheet available
Scientific titleTriple 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 acronymTAP-RISHCC
Study objectivesTransarterial 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) studiedAdjuvant therapy in intermediate-stage hepatocellular carcinoma
InterventionThis 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 typeDrug
Pharmaceutical study type(s)Not Applicable
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Lenvatinib, sintilimab, camrelizumab, tislelizumab, pembrolizumab
Primary outcome measureDisease-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
Secondary outcome measuresThe following secondary outcome measures were assessed using retrospective patient data at one timepoint:
1. Overall survival, defined as the period from the time of surgery to the point of death due to hepatocellular carcinoma
2. Safety in patients who received TAP treatment according to National Cancer Institute Common Toxicity Criteria Adverse Events (CTCAE) version 5.0
Overall study start date10/01/2024
Completion date03/10/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants560
Total final enrolment571
Key inclusion criteria1. 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 criteria1. 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 enrolment08/05/2024
Date of final enrolment02/10/2024

Locations

Countries of recruitment

  • China

Study participating centre

West China Hospital
-
Chengdu, Sichuan Province
610000
China

Sponsor information

West China Hospital of Sichuan University
Hospital/treatment centre

No.37 Guoxue Alley, Wuhou District
Chengdu City, Sichuan Province
610041
China

Phone +86 28 8542 2581
Email hxlcyjglb@163.com
Website https://www.wchscu.cn/
ROR logo "ROR" https://ror.org/007mrxy13

Funders

Funder type

Government

National Natural Science Foundation of China
Government organisation / National government
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Location
China
Sichuan Provincial Science and Technology Support Program
Government organisation / Local government
Alternative name(s)
Science and Technology Project of Sichuan, Sichuan Province Science and Technology Support Program, Science and Technology Project of Sichuan Province
Location
China
West China Hospital, Sichuan University
Private sector organisation / Other non-profit organizations
Alternative name(s)
West China Hospital, West China School of Medicine and West China Hospital, Sichuan University, WCH, WCSM/WCH
Location
China

Results and Publications

Intention to publish date12/12/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated will be available upon request from Guanhua Chen, G.H.Chen769@outloom.com

Editorial Notes

25/03/2025: Study'sexistence confirmed by the Biomedical Ethics Review Committee of the West China Hospital, Sichuan University.