Predicting Response to Systemic Therapies for Hepatocellular Carcinoma(HCC)

NCT ID: NCT05543304

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Non-resectable Effect of Drug

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

radiological evaluation

Intervention Type DIAGNOSTIC_TEST

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

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.

radiological evaluation

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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radiological evaluation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Gang Chen, MD

Clinical Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gang Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

Locations

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Gang Chen

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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

Reference Type BACKGROUND
PMID: 30970190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34764464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31900465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33708638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34256065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31907954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34950180 (View on PubMed)

Other Identifiers

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efficacy of systemic therapies

Identifier Type: -

Identifier Source: org_study_id

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