Carcinoma, Pancreatic DuctalPhase 1/2NCT02529579
Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer
A Phase 1/2 study testing iAPA-DC/CTL adoptive cellular immunotherapy and Gemcitabine in people with Carcinoma, Pancreatic Ductal, run by Changhai Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- iAPA-DC/CTL adoptive cellular immunotherapy and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced Pancreatic cancer patients with histological pathology confirmation
- Both gender, aged 18-70 year-old
- Bone marrow functioned well
- Renal function normal
- Liver function normal
- patients are voluntary, and willing to sign informed consent
- expected lifetime was at least 3 months
Who cannot join
- With acute inflammation
- Accompanied with primary malignant tumor other than pancreas
- with autoimmune disease
- using corticosteroid or other suppress immune hormone treatment
- had transplant operation of vital organs
- active hepatitis
Show all 10Show fewer
- HIV positive
- dysfunction in blood coagulation
- serious diseases in circulatory and respiratory systems
- pregnancy or breast-feeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, 200433
zhaoshen Li, MD, 86-21-81873241, zhaoshenlismmu@gmail.com
zhaoshen Li, MD
About this study
The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.
- Conditions
- Carcinoma, Pancreatic Ductal
- Being tested
- iAPA-DC/CTL adoptive cellular immunotherapy, Gemcitabine
- Keywords
- adoptive Cellular Immunotherapy, patient safety, therapeutic effect
- Medical subject headings
- Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iAPA-DC/CTL adoptive cellular immunotherapyOther
twice DC cell infusion and CTL cell infusion for 6 times
GemcitabineDrug
standard Gemcitabine therapy
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | Standard Gemcitabine Therapy Receives: Drug: Gemcitabine |
| cellular immunotherapy & Gemcitabine | Experimental | iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy Receives: Other: iAPA-DC/CTL adoptive cellular immunotherapy; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month SR
6 months survival rate
Measured: 6 months
Secondary outcomes (4)
PFS
progression-Free Survival
Measured: 6 months
OS
Over survival
Measured: 6 months
ORR
Objective Response Rate
Measured: 2 months
QOL
Quality of Life
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ImmunoGene Biotechology Co.,Ltd
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Ii, MD, Principal investigator, Changhai Hosptial,Second Military medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529579
- Sponsor's protocol ID
- cellular immunotherapy
- Status last verified
- Jan 2015
- First submitted
- 18 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02529579
- Acronym / sponsor ID
- cellular immunotherapy
- Conditions
- Carcinoma, Pancreatic Ductal
- Keywords
- adoptive Cellular Immunotherapy, patient safety, therapeutic effect
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- ImmunoGene Biotechology Co.,Ltd
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Aug 2015 (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 aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Active comparator | Drug: GemcitabineStandard Gemcitabine Therapy |
| cellular immunotherapy & Gemcitabine | Experimental | Other: iAPA-DC/CTL adoptive cellular immunotherapy, Drug: GemcitabineiAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced Pancreatic cancer patients with histological pathology confirmation
- Both gender, aged 18-70 year-old
- Bone marrow functioned well
- Renal function normal
- Liver function normal
Key exclusion criteria (10 listed)
- With acute inflammation
- Accompanied with primary malignant tumor other than pancreas
- with autoimmune disease
- using corticosteroid or other suppress immune hormone treatment
- had transplant operation of vital organs
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 |
|---|---|---|
| iAPA-DC/CTL adoptive cellular immunotherapytwice DC cell infusion and CTL cell infusion for 6 times | Other | cellular immunotherapy & Gemcitabine |
| Gemcitabinestandard Gemcitabine therapy | Drug | Gemcitabine, cellular immunotherapy & Gemcitabine |
Primary outcome
6-month SR
Time frame: 6 months
6 months survival rate
4 secondary outcomes
PFS
Time frame: 6 months
OS
Time frame: 6 months
ORR
Time frame: 2 months
QOL
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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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.
Zhaoshen Ii, MD principal investigator
Changhai Hosptial,Second Military medical University
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 iAPA-DC/CTL adoptive cellular immunotherapy and Gemcitabine in people with Carcinoma, Pancreatic Ductal, run by Changhai 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 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 20 Aug 2015. 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 Zhaoshen Li, MD (+86-21-25070552, zhaoshenlismmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month SR (time frame: 6 months). 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 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.