Hepatocellular CarcinomaPhase 1NCT04032392
Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells
A Phase 1 study testing autologous γδT cells in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital at 2 sites in China.
Trial summary
To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma. 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?
- autologous γδT cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 23 Jul 2019to 30 Jul 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 should sign informed consent form voluntarily and comply with the requirements of this study.
- Gender unlimited, age 18 to 70 years old.
- Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
- According to the 2018 edition of the EASL guidelines for primary liver cancer, patients were diagnosed with advanced HBV-related hepatocellular carcinoma (BCLC stage B and C) by pathology and imaging; all patients required antiviral therapy with nucleoside analogues; other treatments (e.g. interventional therapy) at least 2 weeks prior to γδT cell infusion; patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
- Liver function: Child-Pugh class A/B (5-9), Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Expected survival ≥ 6 months.
- Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study.
Who cannot join
- Combine other viral liver diseases or other liver disease patients.
- Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.
- Pregnant or lactating women; patients after organ transplantation; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
- Dysfunction of major organs; patient white blood cell count <1.0×10e9/L, platelet count <60×10e9/L, hemoglobin <86g/L, prothrombin time (INR) >2.3, or prolonged clotting time >6 seconds, serum albumin <28g/L, total bilirubin >51mmol/L, ALT/AST >5 times the upper limit of normal, creatinine >1.5 times the upper limit of normal.
- Combined with other serious organic diseases, mental illnesses, including any uncontrolled clinically significant systemic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.
- Allergic constitution, history of allergies to blood products, known to be allergic to test substances.
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- Immunosuppressive or systemic cytotoxic drugs may require within six months prior to screening or during treatment; 6 months prior to screening accepted other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc.; immunotherapy such as PD-1 and PD-L1 antibodies.
- Patients currently participating in other clinical trials who may violate this treatment plan and observations.
- Those who are unable or unwilling to provide informed consent or who are unable to comply with the research requirements.
- Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed: patients with any serious acute or chronic physical or mental illness, or laboratory abnormalities.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing 302 Hospital of China
Beijing, Beijing Municipality, 100039
Fu-Sheng Wang, MD, 01066933328, fswang302@163.com
Fu-Sheng Wang, MD
Beijing 302 hospital
Beijing, 100039
Yuanyuan Li, Dr, +8601066933333, lyy020818@sina.com
About this study
To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.
Read the detailed description
This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, fresh biopsy and screening, apheresis, γδT cells preparation, treatment and follow-up. The study will evaluate the safety, tolerability and efficacy of autologous γδT cells in patients with advanced hepatitis B related hepatocellular carcinoma (HCC) which are refractory to current treatment.
Stage I comprising a safety cohort of patients to identify a safe dose, Stage II comprising an expanded patient group for response signal identification, Stage III to confirm efficacy and safety.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- autologous γδT cells
- Keywords
- Hepatocellular carcinoma, Hepatitis B
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous γδT cellsBiological
Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
| Study group | Role | What they receive |
|---|---|---|
| Autologous γδT cells | Experimental | Subjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions.
Dose escalation subjects will receive 6 infusions with dose of γδT cells escalation from 1×10e9 to 6×10e9.
Constant dose subjects will have single infusion intravenously at a target dose of 1~2×10e9 γδT cells. Receives: Biological: autologous γδT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
Measured: 14 months
Overall survival (OS)
Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
Measured: 14 months
Secondary outcomes (2)
Objective Response Rate (ORR)
The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the response evaluation criteria in solid tumors (RECIST) guideline.
Measured: 14 months
Patients-based Quality of Life Evaluation
According to the European Organization for Research and Treatment of Cancer (EORTC) quality of life of the core scale criteria QLQ-C30 to evaluate and compare patients life quality before and after treatment.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start23 Jul 2019 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 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.
- 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
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Fu-Sheng Wang, Dr, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032392
- Sponsor's protocol ID
- Beijing302-013
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells
- ClinicalTrials.gov ID
- NCT04032392
- Acronym / sponsor ID
- Beijing302-013
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 23 Jul 2019 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 25 Jul 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.
To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.
Detailed description
This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, fresh biopsy and screening, apheresis, γδT cells preparation, treatment and follow-up. The study will evaluate the safety, tolerability and efficacy of autologous γδT cells in patients with advanced hepatitis B related hepatocellular carcinoma (HCC) which are refractory to current treatment.
Stage I comprising a safety cohort of patients to identify a safe dose, Stage II comprising an expanded patient group for response signal identification, Stage III to confirm efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous γδT cells | Experimental | Biological: autologous γδT cellsSubjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions. Dose escalation subjects will receive 6 infusions with dose of γδT cells escalation from 1×10e9 to 6×10e9. Constant dose subjects will have single infusion intravenously at a target dose of 1~2×10e9 γδT cells. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients should sign informed consent form voluntarily and comply with the requirements of this study.
- Gender unlimited, age 18 to 70 years old.
- Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
- According to the 2018 edition of the EASL guidelines for primary liver cancer, patients were diagnosed with advanced HBV-related hepatocellular carcinoma (BCLC stage B and C) by pathology and imaging; all patients required antiviral therapy with nucleoside analogues; other treatments (e.g. interventional therapy) at least 2 weeks prior to γδT cell infusion; patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
- Liver function: Child-Pugh class A/B (5-9), Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
Key exclusion criteria (10 listed)
- Combine other viral liver diseases or other liver disease patients.
- Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.
- Pregnant or lactating women; patients after organ transplantation; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
- Dysfunction of major organs; patient white blood cell count <1.0×10e9/L, platelet count <60×10e9/L, hemoglobin <86g/L, prothrombin time (INR) >2.3, or prolonged clotting time >6 seconds, serum albumin <28g/L, total bilirubin >51mmol/L, ALT/AST >5 times the upper limit of normal, creatinine >1.5 times the upper limit of normal.
- Combined with other serious organic diseases, mental illnesses, including any uncontrolled clinically significant systemic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.
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 |
|---|---|---|
| autologous γδT cellsCells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred. | Biological | Autologous γδT cells |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 14 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
Overall survival (OS)
Time frame: 14 months
Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: 14 months
Patients-based Quality of Life Evaluation
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Fu-Sheng Wang, Dr principal investigator
Beijing 302 Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous γδT cells in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital at 2 sites 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 7 inclusion and 10 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yuanyuan Li, Dr (+86 01066933333, lyy020818@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: 14 months). 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 25 Jul 2019.