AzTrials
AzTrials

Hepatocellular Carcinoma Non-resectableNCT05543304

Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)

An observational study of Hepatocellular Carcinoma Non-resectable and Effect of Drug, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
radiological evaluation
How many people
200 participants
Where
1 siteChina
Study dates
1 Dec 2018to 1 Dec 2024
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with unresectable HCC who received systemic therapies.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gang Chen

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC) Based on Clinical Variables and Radiomics Data With Machine Learning Methods

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.

Read the detailed description

Although major achievements have been acquired in diagnosis and treatment, the prognosis of hepatocellular carcinoma (HCC) is still unsatisfactory. Liver resection remains the main curative treatment for HCC, but most patients are at an advanced stage when first diagnosed, leading to be not available to curative therapies. There is a variety of treatment options for advanced HCC, such as transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), targeted therapy (sorafenib and lenvatinib), immunotherapy, and the combination of different therapies. However, due to the heterogeneity of HCC, different patients respond differently to systemic therapies. The the overall response rate (ORR) is not satisfactory and most patients can not benefit from the systemic therapies. There is an urgent need to identify patients who are likely to have positive response to systemic therapies at the beginning before treatment. Therefore ,we want to collect the clinical information of patients with advanced HCC treated with systemic therapies, including demographic data , laboratory index, histological features, radiomics data. Patients are followed-up at a interval of 1 month after treatment, and the ORR, overall survival (OS), progression-free survival (PFS) are recorded. Then the treatment response are evaluated and the relationship between the clinical data and efficacy of systemic therapies are explored by machine learning methods. Then models based on clinical features or radiomics features are developed to predict response to different systemic therapies.

Being tested
radiological evaluation
Keywords
Hepatocellular Carcinoma, systemic therapy, immunotherapy, tyrosine kinase inhibitor, treatment response, radiomics, clinical characteristics, machine learning
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiological evaluationDiagnostic test

    All patients with advanced HCC receive imaging evaluation before and after systemic treatments to assess the development of diseases.

Study groups in NCT05543304
Study groupRoleWhat they receive
patients with response to systemic therapiesPatients shown complete response (CR) and partial response (PR) after treatments. The clinical data and radiomics data are collected through electronic medical record system.
Receives: Diagnostic Test: radiological evaluation
patients with no response to systemic therapiesPatients shown progressive disease (PD) and stable disease (SD) after treatments. The clinical data and radiomics data are collected through electronic medical record system.
Receives: Diagnostic Test: radiological evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Tumor response are evaluated to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).

    Measured: 3 months

Secondary outcomes (2)

  1. Overall survival

    Overall survival was defined as the time from treatment to death for any reason.

    Measured: 1 year

  2. Progression free survival

    Progression free survival was defined as the time from treatment to first progression or death.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start1 Dec 2018
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543304
Sponsor's protocol ID
efficacy of systemic therapies
Status last verified
Feb 2023
First submitted
14 Sep 2022
Last updated
13 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.

    PubMed 30970190

  • Llovet 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.

    PubMed 34764464

  • Chen 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.

    PubMed 31900465

  • Chen 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.

    PubMed 33708638

  • Bruix 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.

    PubMed 34256065

  • Spann 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.

    PubMed 31907954

  • Lee 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.

    PubMed 34950180

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma Non-resectable and Effect of Drug, run by First Affiliated Hospital of Wenzhou Medical University 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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?

Results are not available in the source record.

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?

Objective response rate (time frame: 3 months). 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 NCT05543304, which also lists 7 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 13 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in