Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers
CHANCEsub
Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers
1 other identifier
observational
300
1 country
1
Brief Summary
The purpose of this study is to id transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 14, 2022
March 1, 2022
8 months
March 4, 2022
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
up to approximately 2 years
Secondary Outcomes (4)
Specificity
baseline
Sensitivity
baseline
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode
baseline
Accuracy
baseline
Eligibility Criteria
Patients with intermediate HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions.
You may qualify if:
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
- \. Has repeated measurable intrahepatic lesions according to RECIST v1.1;
You may not qualify if:
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Missing follow-up data;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (1)
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
Related Publications (5)
Llovet JM, Villanueva A, Marrero JA, Schwartz M, Meyer T, Galle PR, Lencioni R, Greten TF, Kudo M, Mandrekar SJ, Zhu AX, Finn RS, Roberts LR; AASLD Panel of Experts on Trial Design in HCC. Trial Design and Endpoints in Hepatocellular Carcinoma: AASLD Consensus Conference. Hepatology. 2021 Jan;73 Suppl 1:158-191. doi: 10.1002/hep.31327. Epub 2020 Sep 9. No abstract available.
PMID: 32430997BACKGROUNDLlovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.
PMID: 33479224BACKGROUNDOchoa de Olza M, Navarro Rodrigo B, Zimmermann S, Coukos G. Turning up the heat on non-immunoreactive tumours: opportunities for clinical development. Lancet Oncol. 2020 Sep;21(9):e419-e430. doi: 10.1016/S1470-2045(20)30234-5.
PMID: 32888471BACKGROUNDPinato DJ, Murray SM, Forner A, Kaneko T, Fessas P, Toniutto P, Minguez B, Cacciato V, Avellini C, Diaz A, Boyton RJ, Altmann DM, Goldin RD, Akarca AU, Marafioti T, Mauri FA, Casagrande E, Grillo F, Giannini E, Bhoori S, Mazzaferro V. Trans-arterial chemoembolization as a loco-regional inducer of immunogenic cell death in hepatocellular carcinoma: implications for immunotherapy. J Immunother Cancer. 2021 Sep;9(9):e003311. doi: 10.1136/jitc-2021-003311.
PMID: 34593621BACKGROUNDJin ZC, Zhou JW, Chen JJ, Ding R, Scheiner B, Wang SN, Li HL, Shen QX, Lu QY, Liu Y, Zhang WH, Luo B, Shi HB, Huang M, Wu YM, Yuan CW, Huang MS, Li JP, Wu JB, Zhu XL, Zhong BY, Zhou HF, Wang YQ, Gu SZ, Peng ZY, Zheng CS, Liu RB, Xu GH, Yang WZ, Xu AB, Liu DF, Qi X, Yeo YH, Zhu HD, Zhao Y, Pinato DJ, Ji F, Teng GJ. Longitudinal Body Composition Identifies Hepatocellular Carcinoma With Cachexia Following Combined Immunotherapy and Target Therapy (CHANCE2213). J Cachexia Sarcopenia Muscle. 2024 Dec;15(6):2705-2716. doi: 10.1002/jcsm.13615. Epub 2024 Nov 27.
PMID: 39604073DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gao-Jun Teng, M.D.
Zhongda hospital, Southeast university, Nanjing, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
March 4, 2022
First Posted
March 14, 2022
Study Start
April 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
March 14, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share