Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)
1 other identifier
observational
200
1 country
1
Brief Summary
As the most common type of primary liver cancer, hepatocellular carcinoma (HCC) has become a big challenge all over the world. Most patients are not available to curative resection when first diagnosed. There are a variety of treatment options for advanced HCC. However, due to the heterogeneity of HCC, the overall response rate (ORR) is not high for systemic therapies. Therefore, appropriate selection of patients who are suitable for individual systemic therapies is important for clinical decision-making.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Longer than P75 for all trials
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
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 13, 2023
February 1, 2023
5 years
September 14, 2022
February 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate
Tumor response are evaluated to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
3 months
Secondary Outcomes (2)
Overall survival
1 year
Progression free survival
1 year
Study Arms (2)
patients with response to systemic therapies
Patients shown complete response (CR) and partial response (PR) after treatments. The clinical data and radiomics data are collected through electronic medical record system.
patients with no response to systemic therapies
Patients shown progressive disease (PD) and stable disease (SD) after treatments. The clinical data and radiomics data are collected through electronic medical record system.
Interventions
All patients with advanced HCC receive imaging evaluation before and after systemic treatments to assess the development of diseases.
Eligibility Criteria
Patients with unresectable HCC who received systemic therapies.
You may qualify if:
- clinically or pathologically diagnosed HCC
- Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
- Child-Pugh score of ≤7
- complete clinical and follow-up information
- evaluable efficacy after treatment
- age between 18-80 years old
You may not qualify if:
- with other malignancies
- Eastern Cooperative Oncology Group performance status (ECOG-PS) \>2
- Child-Pugh score of \>7
- incomplete clinical data
- lost to follow up
- unevaluable efficacy after treatment
- age \<18 years old or \>80 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gang Chen
Wenzhou, Zhejiang, 325000, China
Related Publications (7)
Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.
PMID: 30970190BACKGROUNDLlovet JM, Castet F, Heikenwalder M, Maini MK, Mazzaferro V, Pinato DJ, Pikarsky E, Zhu AX, Finn RS. Immunotherapies for hepatocellular carcinoma. Nat Rev Clin Oncol. 2022 Mar;19(3):151-172. doi: 10.1038/s41571-021-00573-2. Epub 2021 Nov 11.
PMID: 34764464BACKGROUNDChen B, Garmire L, Calvisi DF, Chua MS, Kelley RK, Chen X. Harnessing big 'omics' data and AI for drug discovery in hepatocellular carcinoma. Nat Rev Gastroenterol Hepatol. 2020 Apr;17(4):238-251. doi: 10.1038/s41575-019-0240-9. Epub 2020 Jan 3.
PMID: 31900465BACKGROUNDChen M, Cao J, Hu J, Topatana W, Li S, Juengpanich S, Lin J, Tong C, Shen J, Zhang B, Wu J, Pocha C, Kudo M, Amedei A, Trevisani F, Sung PS, Zaydfudim VM, Kanda T, Cai X. Clinical-Radiomic Analysis for Pretreatment Prediction of Objective Response to First Transarterial Chemoembolization in Hepatocellular Carcinoma. Liver Cancer. 2021 Feb;10(1):38-51. doi: 10.1159/000512028. Epub 2021 Jan 7.
PMID: 33708638BACKGROUNDBruix J, Chan SL, Galle PR, Rimassa L, Sangro B. Systemic treatment of hepatocellular carcinoma: An EASL position paper. J Hepatol. 2021 Oct;75(4):960-974. doi: 10.1016/j.jhep.2021.07.004. Epub 2021 Jul 10.
PMID: 34256065BACKGROUNDSpann A, Yasodhara A, Kang J, Watt K, Wang B, Goldenberg A, Bhat M. Applying Machine Learning in Liver Disease and Transplantation: A Comprehensive Review. Hepatology. 2020 Mar;71(3):1093-1105. doi: 10.1002/hep.31103. Epub 2020 Mar 6.
PMID: 31907954BACKGROUNDLee IC, Huang JY, Chen TC, Yen CH, Chiu NC, Hwang HE, Huang JG, Liu CA, Chau GY, Lee RC, Hung YP, Chao Y, Ho SY, Huang YH. Evolutionary Learning-Derived Clinical-Radiomic Models for Predicting Early Recurrence of Hepatocellular Carcinoma after Resection. Liver Cancer. 2021 Sep 20;10(6):572-582. doi: 10.1159/000518728. eCollection 2021 Nov.
PMID: 34950180BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gang Chen, MD,PhD
First Affiliated Hospital of Wenzhou Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor, Principal Investigator
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 16, 2022
Study Start
December 1, 2018
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
February 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share