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

NCT04506398 | Unknown

• 1 other identifier: Renji-IIT-2020-0007
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma Recurrent; Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• molecular-subtype heterogeneity between primary HCC and post-transplant HCC recurrence

  It is defined as the change of HCC molecular subtype by comparing the primary tumor with intrahepatic or intrapulmonary recurrent tumor.

  up to 2 years

Secondary Outcomes (2)

• molecular-subtype

  up to 2 years

• Recurrence-Free Survival (RFS)

  up to 3 years

Study Arms (2)

Retrospective cohort

20 HCC patients experienced post-transplant HCC

Procedure: liver transplant; Diagnostic Test: whole exome sequencing

Perspective cohort

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

Procedure: liver transplant; Diagnostic Test: ctDNA; Diagnostic Test: whole exome sequencing

Interventions

liver transplant 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.

Perspective cohort; Retrospective cohort

ctDNA DIAGNOSTIC_TEST

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

Perspective cohort

whole exome sequencing DIAGNOSTIC_TEST

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

Perspective cohort; Retrospective cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort 1: HCC patients experienced post-transplant HCC Cohort 2: High recurrence-risk HCC patients who underwent liver transplant

You may qualify if:

• 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.)

You may not qualify if:

• History of oncological systemic treatment
• early recurrence(\<6 months)
• multiple organ transplantation

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

Liver Transplantation; Exome

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation; Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Hao Feng, M.D., Ph.D.

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

  STUDY DIRECTOR

Central Study Contacts

Zijie Zhang

CONTACT

008615026626518; sjtuzzj@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 10, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

CN (1)