Hepatocellular CarcinomaPhase 1NCT03966209
Safety and Efficacy of PD-1 Inhibitors in Patients With Liver Transplant
A Phase 1 study testing JS001(PD-1 inhibitor) in people with Hepatocellular Carcinoma and Liver Transplantation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a perspective clinical study to assess the safety and efficacy of PD-1 inhibitors in patients with LT. Eligible patients have recurrent or metastatic cancer after LT, are not amenable to, or refractory after, locoregional therapy or to a curative treatment approach (eg, surgery, or ablation) and have… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplantation
- What is being tested?
- JS001(PD-1 inhibitor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Oct 2022
- Phase
- Phase 1
- 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
- Patients with recurrence or metastases Hepatocellular carcinoma after liver transplantation that not suitable for surgical resection and Local treatments such as radiofrequency ablation, transcatheter arterial embolization and radiotherapy, been treated with sorafenib or other targeted therapy and are either intolerant to this treatment or show radiographic progression after treatment.
- Age 18-70 years old, male or female
- Biopsy shows negative allograft PD-L1 expression
- Child-Pugh score ≤ 6 points (Child-Pugh A)
- Estimated postoperative survival time ≥ 12 weeks
- ECOG score 0-1 points
- Laboratory test indicators: white blood cells ≥ 3.0 × 109 / L, platelets ≥ 80 × 109 / L, hemoglobin ≥ 100g / L; total bilirubin ≤ 2.5 times the upper limit of normal, transaminase (AST, ALT) ≤ 2.5 times Upper limit of normal value, serum creatinine ≤ 1.5 times normal upper limit
- Have sufficient understanding and voluntarily sign informed consent to participate in clinical research
Who cannot join
- Biopsy shows positive allograft PD-L1 expression
- Severe allergic reactions to other monoclonal antibodies
- Have any history of active autoimmune diseases or autoimmune diseases
- The presence of active infection with Hepatitis B or Hepatitis C Virus
- Severe cardiopulmonary dysfunction patients, have high blood pressure and blood pressure can not be controlled with drugs, unstable coronary artery disease (uncontrollable arrhythmia, unstable angina), non-compensatory congestive heart failure, within 6 months Myocardial infarction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Xiangyu Wang, +86-21-64041990 ext. 2220, wang.xiangyu@zs-hospital.sh.cn
About this study
Official title: Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations
This is a perspective clinical study to assess the safety and efficacy of PD-1 inhibitors in patients with LT. Eligible patients have recurrent or metastatic cancer after LT, are not amenable to, or refractory after, locoregional therapy or to a curative treatment approach (eg, surgery, or ablation) and have previously been treated with sorafenib or other targeted therapy, either intolerant to this treatment or show radiographic progression after treatment.
Biopsy is needed to exclude patients with positive allograft PD-L1 expression.
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- Being tested
- JS001(PD-1 inhibitor)
- Keywords
- Checkpoint Inhibitor, Immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS001(PD-1 inhibitor)Drug
240mg I.V. Q3W
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | JS001（PD-1 inhibitor）, 240mg I.V. Q3W, Receives: Drug: JS001(PD-1 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Event Rate
the occurrence rate of serious adverse event after PD-1 inhibitor treatment
Measured: 1.5 years
Acute Graft Rejection Rate
the occurrence rate of acute graft rejection after PD-1 inhibitor treatment
Measured: 1.5 years
Secondary outcomes (3)
Objective Response Rate
Objective Response Rate after PD-1 inhibitor treatment
Measured: 3 years
Progression Free Survival Rate
survival time after PD-1 inhibitor treatment till tumor progression
Measured: 3 years
Over all survival Rate
survival time after PD-1 inhibitor treatment till patient death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 May 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Oct 2022 (estimated)
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 Shanghai Zhongshan 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966209
- Sponsor's protocol ID
- JS001LT
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations
- ClinicalTrials.gov ID
- NCT03966209
- Acronym / sponsor ID
- JS001LT
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- Keywords
- Checkpoint Inhibitor, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 29 May 2019 (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.
This is a perspective clinical study to assess the safety and efficacy of PD-1 inhibitors in patients with LT. Eligible patients have recurrent or metastatic cancer after LT, are not amenable to, or refractory after, locoregional therapy or to a curative treatment approach (eg, surgery, or ablation) and have previously been treated with sorafenib or other targeted therapy, either intolerant to this treatment or show radiographic progression after treatment.
Biopsy is needed to exclude patients with positive allograft PD-L1 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: JS001(PD-1 inhibitor)JS001（PD-1 inhibitor）, 240mg I.V. Q3W, |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with recurrence or metastases Hepatocellular carcinoma after liver transplantation that not suitable for surgical resection and Local treatments such as radiofrequency ablation, transcatheter arterial embolization and radiotherapy, been treated with sorafenib or other targeted therapy and are either intolerant to this treatment or show radiographic progression after treatment.
- Age 18-70 years old, male or female
- Biopsy shows negative allograft PD-L1 expression
- Child-Pugh score ≤ 6 points (Child-Pugh A)
- Estimated postoperative survival time ≥ 12 weeks
Key exclusion criteria (5 listed)
- Biopsy shows positive allograft PD-L1 expression
- Severe allergic reactions to other monoclonal antibodies
- Have any history of active autoimmune diseases or autoimmune diseases
- The presence of active infection with Hepatitis B or Hepatitis C Virus
- Severe cardiopulmonary dysfunction patients, have high blood pressure and blood pressure can not be controlled with drugs, unstable coronary artery disease (uncontrollable arrhythmia, unstable angina), non-compensatory congestive heart failure, within 6 months Myocardial infarction
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 |
|---|---|---|
| JS001(PD-1 inhibitor)240mg I.V. Q3W | Drug | treatment |
Primary outcome
Serious Adverse Event Rate
Time frame: 1.5 years
the occurrence rate of serious adverse event after PD-1 inhibitor treatment
Acute Graft Rejection Rate
Time frame: 1.5 years
the occurrence rate of acute graft rejection after PD-1 inhibitor treatment
3 secondary outcomes
Objective Response Rate
Time frame: 3 years
Progression Free Survival Rate
Time frame: 3 years
Over all survival Rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS001(PD-1 inhibitor) in people with Hepatocellular Carcinoma and Liver Transplantation, run by Shanghai Zhongshan 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 8 inclusion and 5 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 31 May 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaowu Huang, M.D. (+86-13701811021, huang.xiaowu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Event Rate (time frame: 1.5 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 31 May 2019.