Clinical trial · Observational
Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence
Translational Study of Molecular-subtype Heterogeneity and Evolution Pattern in Patients With hepatoceLlular Carcinoma Post-transplant Relapse - HELP 2020 Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Recurrent | — | UNRESOLVED | — |
| Liver Transplant; Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA | Diagnostic Test | — | UNRESOLVED |
| liver transplant | Procedure | — | UNRESOLVED |
| whole exome sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- 20 HCC patients experienced post-transplant HCC
- interventionNames
- Procedure: liver transplant
- Diagnostic Test: whole exome sequencing
- label
- 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
- interventionNames
- Procedure: liver transplant
- Diagnostic Test: ctDNA
- Diagnostic Test: whole exome sequencing
Primary outcomes (1)
- measure
- molecular-subtype heterogeneity between primary HCC and post-transplant HCC recurrence
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available