Clinical trial NCT04506398: Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence
Official title: Translational Study of Molecular-subtype Heterogeneity and Evolution Pattern in Patients With hepatoceLlular Carcinoma Post-transplant Relapse - HELP 2020 Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma Recurrent
Liver Transplant; Complications
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: molecular-subtype heterogeneity between primary HCC and post-transplant HCC recurrence
timeFrame: up to 2 years
Secondary outcomes:
measure: molecular-subtype
timeFrame: up to 2 years
measure: Recurrence-Free Survival (RFS)
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Dept. of Liver surgery, Renji Hospital, Medical School of Shanghai Jiaotong University
name: Hao Feng, M.D., Ph.D.
role: STUDY_DIRECTOR
References: