Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence (HELP-2020)

Shanghai Jiao Tong University

Status: Unknown

Conditions: Hepatocellular Carcinoma Recurrent; Liver Transplant; Complications

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

Study type: Observational

Funder types: Other

Identifiers

NCT04506398

Renji-IIT-2020-0007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Retrospective cohort

Description:

20 HCC patients experienced post-transplant HCC

Treatment:

Procedure: liver transplant

Diagnostic Test: whole exome sequencing

Perspective cohort

Description:

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

Treatment:

Procedure: liver transplant

Diagnostic Test: whole exome sequencing

Diagnostic Test: ctDNA