Gastric CarcinomaPhase 1/2NCT02317471
Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
A Phase 1/2 study testing autologous gp96 vaccination and Oxaliplatin+S-1 in people with Gastric Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- autologous gp96 vaccination and Oxaliplatin+S-1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2017
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
- Able to read and understand the informed consent document, must sign the informed consent
- Age: 18 to 75 years old
- Availability of at least 0.5 g tumor sample
- ECOG ≤1；life expectancy >=12 weeks, able to comply with study-related procedures
- 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 bilirubin (total) <1.5 times IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs)
- Normal heart function
- NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.
Who cannot join
- Unable to get the informed consent
- Female patients who are pregnant or breastfeeding
- Progression prior to treatment as determined by the principal investigator
- Transplant recipient
- Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection
- Unstable or severe intercurrent medical conditions
- Patient with allergic constitution
- Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Zheng Peng, MD, 086-10-66938028, zihpeng@sina.com
Lin Chen, MD
About this study
The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
- Conditions
- Gastric Carcinoma
- Being tested
- autologous gp96 vaccination, Oxaliplatin+S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous gp96 vaccinationBiological
Vaccination of gp96 derived from autologous tumor tissue. Treatment will be started between 3-6 weeks after the surgery.
gp96 of 25ug in 1mL normal saline s.c. on days 1 of each cycle, up to a maximum of 10 doses (1 cycle= 7 days). 200-400mg cyclophosphamide i.v. 1-3 days before each gp96 infusion.
Oxaliplatin+S-1Drug
Also called Oxaliplatin(Sanofi-aventis), S-1(Taiho)
Treatment will be start at the 5th week after the surgery.
S-1: 40~60mg bid，d1~14 q3W; oxaliplatin:130mg/m2，iv drip for 2h，d1,q3W 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| gp96 group | Experimental | autologous gp96 vaccination + basal treatment for gastric cancer Receives: Biological: autologous gp96 vaccination; Drug: Oxaliplatin+S-1 |
| control group | Other | Oxaliplatin+S-1 Receives: Drug: Oxaliplatin+S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 2 years
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 3.0 criteria.
Measured: participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.
Secondary outcomes (2)
Changes in antigen specific T cells
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 3 days after the 10th vaccination
Overall survival
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 posted16 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cure&Sure Biotech Co., LTD
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
- Investigators
- Lin Chen, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317471
- Sponsor's protocol ID
- PLAG-CS-Ga-01
- Status last verified
- Jun 2016
- First submitted
- 10 Dec 2014
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96
- ClinicalTrials.gov ID
- NCT02317471
- Acronym / sponsor ID
- PLAG-CS-Ga-01
- Conditions
- Gastric Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Cure&Sure Biotech Co., LTD
- Study start
- Nov 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Dec 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 purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gp96 group | Experimental | Biological: autologous gp96 vaccination, Drug: Oxaliplatin+S-1autologous gp96 vaccination + basal treatment for gastric cancer |
| control group | Other | Drug: Oxaliplatin+S-1Oxaliplatin+S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
- Able to read and understand the informed consent document, must sign the informed consent
- Age: 18 to 75 years old
- Availability of at least 0.5 g tumor sample
- ECOG ≤1；life expectancy >=12 weeks, able to comply with study-related procedures
Key exclusion criteria (8 listed)
- Unable to get the informed consent
- Female patients who are pregnant or breastfeeding
- Progression prior to treatment as determined by the principal investigator
- Transplant recipient
- Patients currently diagnosed with Human Immunodeficiency Virus or other 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 |
|---|---|---|
| autologous gp96 vaccinationVaccination of gp96 derived from autologous tumor tissue. Treatment will be started between 3-6 weeks after the surgery. gp96 of 25ug in 1mL normal saline s.c. on days 1 of each cycle, up to a maximum of 10 doses (1 cycle= 7 days). 200-400mg cyclophosphamide i.v. 1-3 days before each gp96 infusion. | Biological | gp96 group |
| Oxaliplatin+S-1Also: Oxaliplatin(Sanofi-aventis), S-1(Taiho)Treatment will be start at the 5th week after the surgery. S-1: 40~60mg bid，d1~14 q3W; oxaliplatin:130mg/m2，iv drip for 2h，d1,q3W 6 cycles. | Drug | control group, gp96 group |
Primary outcome
Disease free survival
Time frame: 2 years
Number of participants with adverse events related to gp96 immunotherapy
Time frame: participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.
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 3.0 criteria.
2 secondary outcomes
Changes in antigen specific T cells
Time frame: within 3 days before the first vaccination and within 3 days after the 10th vaccination
Overall survival
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 6 Jun 2016.
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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.
Lin Chen, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous gp96 vaccination and Oxaliplatin+S-1 in people with Gastric Carcinoma, run by Chinese PLA General 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 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 6 Jun 2016. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Peng, MD (086-10-66938028, zihpeng@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 2 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 6 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.