Translational Study of Molecular-subtype Heterogeneity and Evolution Pattern in Patients With hepatoceLlular Carcinoma Post-transplant Relapse - HELP 2020 Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- RenJi Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- molecular-subtype heterogeneity between primary HCC and post-transplant HCC recurrence
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
molecular-subtype heterogeneity between primary HCC and post-transplant HCC recurrence
Time Frame: up to 2 years
It is defined as the change of HCC molecular subtype by comparing the primary tumor with intrahepatic or intrapulmonary recurrent tumor.
Secondary Outcomes
- molecular-subtype(up to 2 years)
- Recurrence-Free Survival (RFS)(up to 3 years)