Hepatocellular CarcinomaNCT05193253
Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less
An observational study of Hepatocellular Carcinoma, run by University Health Network, Toronto.
Trial summary
Curative-intent therapies for hepatocellular carcinoma (HCC) include radiofrequency ablation (RFA), liver resection (LR), and liver transplantation (LT). Controversy exists in treatment selection for early-stage tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Radiofrequency ablation, Liver resection and Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2000to 21 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years) patients with solitary HCC ≤ 3cm who underwent either RFA, LR, or were listed for an LT between Feb-2000, and Nov-2018.
Who may be able to join
- Adult (≥18 years) patients
- Solitary HCC ≤ 3cm
- Receipt of either radiofrequency ablation, liver resection, or listing for a liver transplant
- Treatment received between Feb-2000 and Nov-2018
Who cannot join
- Pathology other than hepatocellular carcinoma (HCC)
- Receipt of prior treatment (i.e., not treatment naive)
- Not eligible for all of the three treatments (ablation, liver resection, or liver transplant listing)
- Platelet count <100,000 before treatment
- Alpha-1 fetoprotein (AFP) level > 1000 before treatment
- Age > 70 years
Show all 12Show fewer
- Child-Pugh score C
- Esophageal varices grade greater than 2
- Model for End-stage Liver Disease (MELD) score before treatment exceeding 15
- Presence of ascites pretreatment
- Presence of encephalopathy pretreatment
- Spleen size greater than 12 cm
About this study
Official title: Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less Using an Intention-to-treat Analysis: a Retrospective Cohort Study
Curative-intent therapies for hepatocellular carcinoma (HCC) include radiofrequency ablation (RFA), liver resection (LR), and liver transplantation (LT). Controversy exists in treatment selection for early-stage tumors. We sought to evaluate the oncologic outcomes of patients who received either RFA, LR, or LT as first-line treatment for solitary HCC ≤ 3cm in an intention-to-treat analysis.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Radiofrequency ablation, Liver resection, Liver transplantation
- Keywords
- liver transplant, liver resection, radiofrequency ablation, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Treatment-naive patients with solitary HCC <= 3 cm who received ablation as the first-line treatment
Liver resectionProcedure or surgery
Treatment-naive patients with solitary HCC <= 3 cm who underwent liver resection as the first-line treatment
Liver transplantationProcedure or surgery
Treatment-naive patients with solitary HCC <= 3 cm who were listed for liver transplantation as the first-line treatment
| Study group | Role | What they receive |
|---|---|---|
| Solitary HCC <= 3 cm | Treatment-naive patients with HCC <= 3 cm Receives: Procedure: Radiofrequency ablation; Procedure: Liver resection; Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention-to-treat (ITT) overall survival
ITT was evaluated from the first treatment modality that was selected for curative intent. In the case of RFA and LR this was recorded as the time of the treatment. In the case of LT, the intention-to-treat was recorded at the time of listing for transplantation. The ITT analysis thus accounted for patients who were placed on the waitlist but dropped out.
Measured: Overall (median length of follow up of entire cohort 6.6 years)
Disease-free survival (DFS).
DFS was defined as the time after treatment during which the patient was alive and free of disease. For DFS, patients were censored at recurrence, death, or loss to follow up.
Measured: Overall (median length of follow up of entire cohort 6.6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Feb 2000
- Primary completion30 Nov 2018
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193253
- Sponsor's protocol ID
- 16-5285.6
- Status last verified
- Dec 2021
- First submitted
- 31 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are unsuitable to post given that they contain potentially identifiable patient information. Moreover, the research ethics board at the University Health Network has only approved data to be stored and analyzed by the members of the institutional study team to minimize any breach of patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less Using an Intention-to-treat Analysis: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05193253
- Acronym / sponsor ID
- 16-5285.6
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver transplant, liver resection, radiofrequency ablation, hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Feb 2000 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 14 Jan 2022 (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.
Curative-intent therapies for hepatocellular carcinoma (HCC) include radiofrequency ablation (RFA), liver resection (LR), and liver transplantation (LT). Controversy exists in treatment selection for early-stage tumors. We sought to evaluate the oncologic outcomes of patients who received either RFA, LR, or LT as first-line treatment for solitary HCC ≤ 3cm in an intention-to-treat analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solitary HCC <= 3 cm | – | Procedure: Radiofrequency ablation, Procedure: Liver resection, Procedure: Liver transplantationTreatment-naive patients with HCC <= 3 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) patients with solitary HCC ≤ 3cm who underwent either RFA, LR, or were listed for an LT between Feb-2000, and Nov-2018.
Key inclusion criteria (4 listed)
- Adult (≥18 years) patients
- Solitary HCC ≤ 3cm
- Receipt of either radiofrequency ablation, liver resection, or listing for a liver transplant
- Treatment received between Feb-2000 and Nov-2018
Key exclusion criteria (12 listed)
- Pathology other than hepatocellular carcinoma (HCC)
- Receipt of prior treatment (i.e., not treatment naive)
- Not eligible for all of the three treatments (ablation, liver resection, or liver transplant listing)
- Platelet count <100,000 before treatment
- Alpha-1 fetoprotein (AFP) level > 1000 before treatment
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 |
|---|---|---|
| Radiofrequency ablationTreatment-naive patients with solitary HCC <= 3 cm who received ablation as the first-line treatment | Procedure or surgery | Solitary HCC <= 3 cm |
| Liver resectionTreatment-naive patients with solitary HCC <= 3 cm who underwent liver resection as the first-line treatment | Procedure or surgery | Solitary HCC <= 3 cm |
| Liver transplantationTreatment-naive patients with solitary HCC <= 3 cm who were listed for liver transplantation as the first-line treatment | Procedure or surgery | Solitary HCC <= 3 cm |
Primary outcome
Intention-to-treat (ITT) overall survival
Time frame: Overall (median length of follow up of entire cohort 6.6 years)
ITT was evaluated from the first treatment modality that was selected for curative intent. In the case of RFA and LR this was recorded as the time of the treatment. In the case of LT, the intention-to-treat was recorded at the time of listing for transplantation. The ITT analysis thus accounted for patients who were placed on the waitlist but dropped out.
Disease-free survival (DFS).
Time frame: Overall (median length of follow up of entire cohort 6.6 years)
DFS was defined as the time after treatment during which the patient was alive and free of disease. For DFS, patients were censored at recurrence, death, or loss to follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No. The data that support the findings of this study are unsuitable to post given that they contain potentially identifiable patient information. Moreover, the research ethics board at the University Health Network has only approved data to be stored and analyzed by the members of the institutional study team to minimize any breach of patient confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University Health Network, Toronto.
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 12 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: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention-to-treat (ITT) overall survival (time frame: Overall (median length of follow up of entire cohort 6.6 years)). The study lists 2 primary outcomes in all. 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 18 Jan 2022.