Liver CancerPhase 2/3NCT04206254
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver Cancer
A Phase 2/3 study testing gp96 in people with Liver Cancer, run by Cure&Sure Biotech Co., LTD.
Trial summary
This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- gp96
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2019to 5 Aug 2023
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read and understand the informed consent document; must sign the informed consent;
- Aged 18 to 75 years old , sex is not limited;
- must have undergone radical resection;AJCC TNM II、III、IV.
- Availability of at least 1g tumor sample;
- Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs)
- Agree to Surgical indications of Heart \& lung and without the coagulation system disease
- Patients could not have received previous anti-cancer treat before 4 weeks of gp96 treatment；
Who cannot join
- Inability to comply with study-related procedures
- Unavailability of at least 6 doses of vaccine
- Severe allergies
- Unstable or severe intercurrent medical conditions
- Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
- patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
- Female patients who are pregnant or breastfeeding
- Steroidal drugs are currently being used systemically.
About this study
Official title: GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver
This trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work
Read the detailed description
RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work.
Secondary Aims:
to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.
- Conditions
- Liver Cancer
- Being tested
- gp96
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp96Biological
heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| gp96 group | Experimental | Patients only receive autologous gp96 vaccination after surgery (do not accept other anti-tumor treatments)
6 times of gp96 vaccination are administered via subcutaneous injection in 25μg doses within 8 weeks after surgery. gp96 is administered once a week. Receives: Biological: gp96 |
| Control group | No intervention | Patients do not accept any anti-tumor treatmentsafter surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival rate
Measured: 2 year
Secondary outcomes (4)
Disease free survival
Measured: 5 year
changes in antigen specific T cells
tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen
Measured: within 3 days before the first vaccination and within 10 days after the last vaccination
Number of participants with adverse events related to gp96 immunotherapy
A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.
Measured: up to 3 months after vaccine completion
Overall survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start19 Dec 2019 (estimated)
- Primary completion5 Aug 2022 (estimated)
- Study completion5 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cure&Sure Biotech Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206254
- Sponsor's protocol ID
- CS-CH-19
- Status last verified
- Aug 2019
- First submitted
- 18 Dec 2019
- Last updated
- 20 Dec 2019
- 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Liver
- ClinicalTrials.gov ID
- NCT04206254
- Acronym / sponsor ID
- CS-CH-19
- Conditions
- Liver Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cure&Sure Biotech Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 19 Dec 2019 (estimated)
- Primary completion
- 5 Aug 2022 (estimated)
- Study completion
- 5 Aug 2023 (estimated)
- First posted
- 20 Dec 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 trial is to further study the safety and effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work
Detailed description
RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to further evaluate effectiveness of autologous gp96 treatment of liver cancer on the basis of preliminary work.
Secondary Aims:
to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gp96 group | Experimental | Biological: gp96Patients only receive autologous gp96 vaccination after surgery (do not accept other anti-tumor treatments) 6 times of gp96 vaccination are administered via subcutaneous injection in 25μg doses within 8 weeks after surgery. gp96 is administered once a week. |
| Control group | No intervention | –Patients do not accept any anti-tumor treatmentsafter surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to read and understand the informed consent document; must sign the informed consent;
- Aged 18 to 75 years old , sex is not limited;
- must have undergone radical resection;AJCC TNM II、III、IV.
- Availability of at least 1g tumor sample;
- Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and adequate renal function (BUN and creatinine <1.5 times IULNs)
Key exclusion criteria (8 listed)
- Inability to comply with study-related procedures
- Unavailability of at least 6 doses of vaccine
- Severe allergies
- Unstable or severe intercurrent medical conditions
- Current diagnosis of Human Immunodeficiency Virus and Patients with active uncontrolled infection.
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 |
|---|---|---|
| gp96heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. | Biological | gp96 group |
Primary outcome
2-year recurrence-free survival rate
Time frame: 2 year
4 secondary outcomes
Disease free survival
Time frame: 5 year
changes in antigen specific T cells
Time frame: within 3 days before the first vaccination and within 10 days after the last vaccination
Number of participants with adverse events related to gp96 immunotherapy
Time frame: up to 3 months after vaccine completion
Overall survival
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing gp96 in people with Liver Cancer, run by Cure&Sure Biotech Co., LTD.
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 8 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 20 Dec 2019. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
2-year recurrence-free survival rate (time frame: 2 year). 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 20 Dec 2019.