Pancreatic Ductal AdenocarcinomaEarly Phase 1AKTNCT02929797
Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer
A Early Phase 1 study testing CD8+NKG2D+ AKT Cell and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- CD8+NKG2D+ AKT Cell and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2016to Aug 2019
- 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
- 1. Diagnosed as stage II-III pancreatic ductal adenocarcinoma patients by pathologic histology;
- 2. Pancreatic cancer after radical resection;
- 3. Eastern Cooperative Oncology Group Performance Status less than 2;
- 4. Without radiotherapy or neoadjuvant chemotherapy;
- 5. The man or the gestation and lactation women Age between 18 to 80 years old;
- 6. Bone marrow functioned well: ANC more than 1.5*10^9/ L, PLT more than 100*10^9/LHgb more than 9 g/dL;
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- 7. Blood biochemical indicators: AST（SGOT）less than 1.5 ULNALT（SGPT）less than 1.5 ULN, TBIL less than 1.5 ULN;
- 8. PT and PPT are in normal ranges;
- 9. Three months prior to clinical research did not receive any other clinical research trials;
- 10. patients are voluntary, and willing to sign informed consent.
Who cannot join
- 1. Patients with other malignant tumors in the past five years;
- 2. Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment;
- 3. Known as HIV infection, active hepatitis B virus or hepatitis C virus infection;
- 4. Known allergy to any kind of component of study drugs;
- 5. History of connective tissue disease(Such as lupus, scleroderma, nodular arteritis);
- 6. Patients with a history of interstitial pneumoniaSlowly progressive difficulty in breathing and hoose Sarcoidosissilicosis Fibrose pulmonaire idiopathiquehylactic pneumonia or A variety of allergy;
- 7. Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements;
- 8. At the same time Patients participate in any other use of interventional medicine clinical research or checkers.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 201620
Shupeng Guo, Dr, 18817943845, gsp88@foxmail.com
- Recruiting
Shanghai General Hospital
Shanghai, 201620
Shupeng Guo, Dr, 18817943845, gsp88@foxmail.com
About this study
Official title: A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy
A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- CD8+NKG2D+ AKT Cell, Gemcitabine
- Keywords
- pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD8+NKG2D+ AKT CellBiological
Also called AKT
AKT: CD8+NKG2D+ AKT cell
GemcitabineDrug
Also called GEM
gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| AKT + gemcitabine | Experimental | gemcitabine dose 1000mg/M^2, d1,8,15，q4w ×6 AKT 5*10^8/M^2, d16,q4w ×6 Drug: gemcitabine Biological: AKT, CD8+NKG2D+ AKT Cell Receives: Biological: CD8+NKG2D+ AKT Cell; Drug: Gemcitabine |
| gemcitabine | Active comparator | gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 1 year
Secondary outcomes (3)
Overall Survival
Measured: 3 years
immune indices
Measured: 1 year
Quality of life
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 posted11 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Principal investigator, Hongxia Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- hongxia Wang, Dr., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929797
- Sponsor's protocol ID
- CD8+NKG2D+ AKT
- Acronym
- AKT
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2016
- Last updated
- 11 Oct 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 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02929797
- Acronym / sponsor ID
- AKT / CD8+NKG2D+ AKT
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- pancreatic cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 11 Oct 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.
A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKT + gemcitabine | Experimental | Biological: CD8+NKG2D+ AKT Cell, Drug: Gemcitabinegemcitabine dose 1000mg/M^2, d1,8,15，q4w ×6 AKT 5*10^8/M^2, d16,q4w ×6 Drug: gemcitabine Biological: AKT, CD8+NKG2D+ AKT Cell |
| gemcitabine | Active comparator | Drug: Gemcitabinegemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Diagnosed as stage II-III pancreatic ductal adenocarcinoma patients by pathologic histology;
- 2. Pancreatic cancer after radical resection;
- 3. Eastern Cooperative Oncology Group Performance Status less than 2;
- 4. Without radiotherapy or neoadjuvant chemotherapy;
- 5. The man or the gestation and lactation women Age between 18 to 80 years old;
Key exclusion criteria (8 listed)
- 1. Patients with other malignant tumors in the past five years;
- 2. Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment;
- 3. Known as HIV infection, active hepatitis B virus or hepatitis C virus infection;
- 4. Known allergy to any kind of component of study drugs;
- 5. History of connective tissue disease(Such as lupus, scleroderma, nodular arteritis);
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 |
|---|---|---|
| CD8+NKG2D+ AKT CellAlso: AKTAKT: CD8+NKG2D+ AKT cell | Biological | AKT + gemcitabine |
| GemcitabineAlso: GEMgemcitabine | Drug | AKT + gemcitabine, gemcitabine |
Primary outcome
Disease-free survival
Time frame: 1 year
3 secondary outcomes
Overall Survival
Time frame: 3 years
immune indices
Time frame: 1 year
Quality of life
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 11 Oct 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.
hongxia Wang, Dr. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD8+NKG2D+ AKT Cell and Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 10 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 11 Oct 2016. 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?
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 hongxia Wang, Dr. (8621-63240090, whx365@126.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: 1 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 11 Oct 2016.