Hepatocellular CarcinomaPhase 2NCT02129322
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1
A Phase 2 study testing Sorafenib, S-1 and Oxaliplatin in people with Hepatocellular Carcinoma, run by Zhejiang University at 1 site in China.
Trial summary
The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib, S-1 and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2019
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatocellular carcinoma after liver transplantation
- Major organ (heart, lung and brain) function was normal
Who cannot join
- Any active infectious process
- The presence of clinically confirmed extrahepatic metastasis
- Postoperative dysfunction of any organ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1o Prevent the Tumor Recurrence for Hepatocellular Carcinoma After Liver Transplantation: A Randomized Controlled Study
The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib, S-1, Oxaliplatin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
S-1Drug
OxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Active comparator | Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance Receives: Drug: Sorafenib; Drug: S-1; Drug: Oxaliplatin |
| S-1 and Sorafenib | Experimental | Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance Receives: Drug: Sorafenib; Drug: S-1; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrence (TTR)
Time to Recurrence
Measured: within five years after liver transplantation
Secondary outcomes (1)
Overall survival (OS)
Overall survival
Measured: within the five years after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startJul 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: patients not enrolled
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 Zhejiang UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- Weijia fang, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129322
- Sponsor's protocol ID
- ZYYYMedOncoLT01
- Status last verified
- Feb 2021
- First submitted
- 28 Apr 2014
- Last updated
- 15 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1o Prevent the Tumor Recurrence for Hepatocellular Carcinoma After Liver Transplantation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02129322
- Acronym / sponsor ID
- ZYYYMedOncoLT01
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: patients not enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 May 2014 (estimated)
- 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.
The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Active comparator | Drug: Sorafenib, Drug: S-1, Drug: OxaliplatinLeading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance |
| S-1 and Sorafenib | Experimental | Drug: Sorafenib, Drug: S-1, Drug: OxaliplatinLeading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hepatocellular carcinoma after liver transplantation
- Major organ (heart, lung and brain) function was normal
Key exclusion criteria (3 listed)
- Any active infectious process
- The presence of clinically confirmed extrahepatic metastasis
- Postoperative dysfunction of any organ
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 |
|---|---|---|
| Sorafenib | Drug | S-1 and Sorafenib, Sorafenib |
| S-1 | Drug | S-1 and Sorafenib, Sorafenib |
| Oxaliplatin | Drug | S-1 and Sorafenib, Sorafenib |
Primary outcome
Time to Recurrence (TTR)
Time frame: within five years after liver transplantation
Time to Recurrence
1 secondary outcome
Overall survival (OS)
Time frame: within the five years after liver transplantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
Weijia fang principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib, S-1 and Oxaliplatin in people with Hepatocellular Carcinoma, run by Zhejiang University 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 2 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: withdrawn, as of the sponsor's last update on 15 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to Recurrence (TTR) (time frame: within five years after liver transplantation). 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 15 Feb 2021.