Gastric Cancer.Early Phase 1NCT02704299
The Study of Surgery,Chemotherapy and Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
A Early Phase 1 study testing Autologous T cells-Based Immunotherapy in people with Gastric Cancer., run by Shanghai AbelZeta Ltd..
Trial summary
Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer.
- What is being tested?
- Autologous T cells-Based Immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2018
- Phase
- Early 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 to 80 years, males and females.
- Subjects who understand and sign the consent form for this study.
- The pathologically confirmed advanced gastric cancer T3、T4 or T2 and Metastasis in lymph nodes.
- Subjects are surgical candidates.
- No distant metastasis (M0) and No distant lymph node metastasis.
- Expected survival time of at least 6 months.
Who cannot join
- Subjects who do not sign the consent form for this study.
- The subject has an allergic history of medicine or food.
- The subject has uncontrolled or hard-to-control diseases of cardiovascular,liver,kidney or lung,endocrine system.
- The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
- The subject has an history of other malignant tumour.
- The subject has history of alcoholism, drug abuse, or mental illness in the 12 years prior to this trial.
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- The subject has participated in any other clinical trial in the 3 months prior to this trial.
- The subject is pregnant, lactating or planning to conceive within the next 24 months.
- The subject has any other unsuitable or adverse condition to be determined by the investigator.
Trial locations and contacts
No sites are listed yet.
Jiafu / Ji, Doctor contact
About this study
Official title: A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.
Read the detailed description
Safety:AE/SAE Efficacy:immunologic function;FPS
- Conditions
- Gastric Cancer.
- Being tested
- Autologous T cells-Based Immunotherapy
- 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 T cells-Based ImmunotherapyBiological
Also called TCM
TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.
| Study group | Role | What they receive |
|---|---|---|
| Autologous T cells-Based Immunotherapy | Experimental | Surgery Chemotherapy Autologous T cells-Based Immunotherapy Receives: Biological: Autologous T cells-Based Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival(PFS)
The primary objective is to assess progression free survival (PFS).
Measured: 24months
Secondary outcomes (1)
Incidences of adverse events or serious adverse events
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer.Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704299
- Sponsor's protocol ID
- CBMG-TCM-GC-1.1
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2016
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centered Clinical Trial of Surgery，Chemotherapy in Combination With Autologous T Cells-Based Immunotherapy for Advanced Gastric Cancer.
- ClinicalTrials.gov ID
- NCT02704299
- Acronym / sponsor ID
- CBMG-TCM-GC-1.1
- Conditions
- Gastric Cancer.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai AbelZeta Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- Mar 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Mar 2016 (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.
Evaluate the feasibility ,safety and efficacy of Surgery，Chemotherapy in Combination with Autologous T cells-Based Immunotherapy for Advanced Gastric Cancer.
Detailed description
Safety:AE/SAE Efficacy:immunologic function;FPS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous T cells-Based Immunotherapy | Experimental | Biological: Autologous T cells-Based ImmunotherapySurgery Chemotherapy Autologous T cells-Based Immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 to 80 years, males and females.
- Subjects who understand and sign the consent form for this study.
- The pathologically confirmed advanced gastric cancer T3、T4 or T2 and Metastasis in lymph nodes.
- Subjects are surgical candidates.
- No distant metastasis (M0) and No distant lymph node metastasis.
Key exclusion criteria (9 listed)
- Subjects who do not sign the consent form for this study.
- The subject has an allergic history of medicine or food.
- The subject has uncontrolled or hard-to-control diseases of cardiovascular,liver,kidney or lung,endocrine system.
- The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.
- The subject has an history of other malignant tumour.
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 T cells-Based ImmunotherapyAlso: TCMTCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity. | Biological | Autologous T cells-Based Immunotherapy |
Primary outcome
Progression-Free-Survival(PFS)
Time frame: 24months
The primary objective is to assess progression free survival (PFS).
1 secondary outcome
Incidences of adverse events or serious adverse events
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jiafu / Ji, Doctor contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous T cells-Based Immunotherapy in people with Gastric Cancer., run by Shanghai AbelZeta 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 6 inclusion and 9 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 11 Mar 2016. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jiafu / Ji, Doctor, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival(PFS) (time frame: 24months). 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 11 Mar 2016.