Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence

NCT ID: NCT04506398

Last Updated: 2021-06-24

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-10

Study Completion Date

2022-08-31

Brief Summary

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Objective of Study: This study will evaluate the heterogeneity and evolution pathway between primary HCC and tumor relapse after liver transplant.

According to the "Seed-Soil" theory, the primary hypothesis of this study is that HCC patients with different molecular-subtype experience altered different pattern of post-transplant recurrence, thus may have altered postoperative Recurrence-Free Survival (RFS). Because the donors' liver construct different microenvironment for CTC(circulating tumor cells) colonization. The investigators design this translational study to ①explore potential high recurrent risk HCC molecular-subtypes which might benefit from neoadjuvant systematic therapy or early adjuvant systematic therapy;②identify the molecular subtype heterogeneity of primary and recurrent HCC to guide the precision medicine.

Detailed Description

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40 specimens will be obtained from the primary tumor during liver transplant surgery and biopsy/specimens from intrahepatic tumor or lung metastasis when the patients experience postoperative relapse. The molecular-subtype of HCC will be determined via whole exom sequence(WES), immunohistochemistry(IHC) and RNA-Seq.

Conditions

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Hepatocellular Carcinoma Recurrent Liver Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective cohort

20 HCC patients experienced post-transplant HCC

liver transplant

Intervention Type PROCEDURE

Liver transplantation for hepatocellular carcinoma has the potential to eliminate both the tumor as well as the underlying cirrhosis and is the ideal treatment for HCC in cirrhotic liver as well as massive HCC in noncirrhotic liver.

whole exome sequencing

Intervention Type DIAGNOSTIC_TEST

xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.

Perspective cohort

20 HCC patients who underwent liver transplant, the patients would be recruited if recurrence would be diagnosed \>6 months after liver transplant

liver transplant

Intervention Type PROCEDURE

Liver transplantation for hepatocellular carcinoma has the potential to eliminate both the tumor as well as the underlying cirrhosis and is the ideal treatment for HCC in cirrhotic liver as well as massive HCC in noncirrhotic liver.

ctDNA

Intervention Type DIAGNOSTIC_TEST

Circulating Tumor DNA Correlates With Microvascular Invasion and Predicts Tumor Recurrence of Hepatocellular Carcinoma

whole exome sequencing

Intervention Type DIAGNOSTIC_TEST

xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.

Interventions

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liver transplant

Liver transplantation for hepatocellular carcinoma has the potential to eliminate both the tumor as well as the underlying cirrhosis and is the ideal treatment for HCC in cirrhotic liver as well as massive HCC in noncirrhotic liver.

Intervention Type PROCEDURE

ctDNA

Circulating Tumor DNA Correlates With Microvascular Invasion and Predicts Tumor Recurrence of Hepatocellular Carcinoma

Intervention Type DIAGNOSTIC_TEST

whole exome sequencing

xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed
* Patients have post-transplant HCC recurrence(cohort 1), Indication for being an candidate in the waiting list for liver transplant according to multidisciplinary board evaluation(cohort 2)
* The time frame between liver transplant and diagnosis of post-transplant HCC recurrence\> 6 months
* No prior hepatectomy or systemic therapy or local therapy (TACE etc.)

Exclusion Criteria

* History of oncological systemic treatment
* early recurrence(\<6 months)
* multiple organ transplantation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hao Feng, M.D., Ph.D.

Role: STUDY_DIRECTOR

Dept. of Liver surgery, Renji Hospital, Medical School of Shanghai Jiaotong University

Locations

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Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zijie Zhang

Role: CONTACT

008615026626518

Facility Contacts

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Hao Feng, MD, PhD

Role: primary

Other Identifiers

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Renji-IIT-2020-0007

Identifier Type: -

Identifier Source: org_study_id

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