Hepatocellular Carcinoma RecurrentHELP-2020NCT04506398
Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence
An observational study of Hepatocellular Carcinoma Recurrent and Liver Transplant; Complications, run by RenJi Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Recurrent, Liver Transplant; Complications
- What is being tested?
- liver transplant, ctDNA and whole exome sequencing
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort 1: HCC patients experienced post-transplant HCC Cohort 2: High recurrence-risk HCC patients who underwent liver transplant
Who may be able to join
- 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.)
Who cannot join
- History of oncological systemic treatment
- early recurrence(<6 months)
- multiple organ transplantation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
Hao Feng, MD, PhD, surgeonfeng@live.com
About this study
Official title: Translational Study of Molecular-subtype Heterogeneity and Evolution Pattern in Patients With hepatoceLlular Carcinoma Post-transplant Relapse - HELP 2020 Cohort Study
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.
Read the 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.
- Being tested
- liver transplant, ctDNA, whole exome sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantProcedure or surgery
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.
ctDNADiagnostic test
Circulating Tumor DNA Correlates With Microvascular Invasion and Predicts Tumor Recurrence of Hepatocellular Carcinoma
whole exome sequencingDiagnostic test
xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | 20 HCC patients experienced post-transplant HCC Receives: 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 Receives: Procedure: liver transplant; Diagnostic Test: ctDNA; Diagnostic Test: whole exome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years
Secondary outcomes (2)
molecular-subtype
I.Progenitor Type: defined by the transcriptional and protein overexpression of hepatic progenitor markers, inactivating mutations in RPS6KA3 and AXIN1 and hyperphosphorylation of ERK. The main signalling pathways specifically activated in the progenitor subclass are IGF1R and AKT.
II.TGFβ-Wnt Type: characterised by activation of both TGFβ and Wnt pathways and an exhausted immune response. Also, an enrichment in TP53 inactivating mutations, amplification of FGF19 and CCND1, as well as frequent activation of pro-survival signalling pathways including cell cycle, mTOR, RAS-MAPK and MET can be detected.
III.G4 Type: It frequently harbour a steatohepatitic phenotype, as well as exhibiting activation of the IL6/JAK-STAT pathway.
IV.CTNNB1 Type: a subset of HCC harbouring CTNNB1 mutations. TERT promoter mutations are more frequent in this subclass
Measured: up to 2 years
Recurrence-Free Survival (RFS)
RFS is defined as the time from inclusion to first documentation of disease recurrence (intrahepatic or intrapulmonary) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start10 Sep 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma RecurrentStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Feng, M.D., Ph.D., Study director, Dept. of Liver surgery, Renji Hospital, Medical School of Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506398
- Sponsor's protocol ID
- Renji-IIT-2020-0007
- Acronym
- HELP-2020
- Status last verified
- Jun 2021
- First submitted
- 6 Aug 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Study of Molecular-subtype Heterogeneity and Evolution Pattern in Patients With hepatoceLlular Carcinoma Post-transplant Relapse - HELP 2020 Cohort Study
- ClinicalTrials.gov ID
- NCT04506398
- Acronym / sponsor ID
- HELP-2020 / Renji-IIT-2020-0007
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Procedure: liver transplant, Diagnostic Test: whole exome sequencing20 HCC patients experienced post-transplant HCC |
| Perspective cohort | – | Procedure: liver transplant, Diagnostic Test: ctDNA, Diagnostic Test: whole exome sequencing20 HCC patients who underwent liver transplant, the patients would be recruited if recurrence would be diagnosed >6 months after liver transplant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: HCC patients experienced post-transplant HCC Cohort 2: High recurrence-risk HCC patients who underwent liver transplant
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (3 listed)
- History of oncological systemic treatment
- early recurrence(<6 months)
- multiple organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver transplantLiver 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. | Procedure or surgery | Perspective cohort, Retrospective cohort |
| ctDNACirculating Tumor DNA Correlates With Microvascular Invasion and Predicts Tumor Recurrence of Hepatocellular Carcinoma | Diagnostic test | Perspective cohort |
| whole exome sequencingxome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence. | Diagnostic test | Perspective cohort, Retrospective cohort |
Primary outcome
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.
2 secondary outcomes
molecular-subtype
Time frame: up to 2 years
Recurrence-Free Survival (RFS)
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Feng, M.D., Ph.D. study director
Dept. of Liver surgery, Renji Hospital, Medical School of Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Recurrent and Liver Transplant; Complications, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zijie Zhang (008615026626518, sjtuzzj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
molecular-subtype heterogeneity between primary HCC and post-transplant HCC recurrence (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.