Pancreatic Cancer Stage IIIPhase 1HSTNCT03236883
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
A Phase 1 study testing Gemcitabine and GPBSC in people with Pancreatic Cancer Stage III and Pancreatic Cancer Stage IV, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV
- What is being tested?
- Gemcitabine and GPBSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Apr 2019
- Phase
- 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
- PET-CT/EUS-FNA cytologically confirmed stage III -Ⅳ of pancreatic cancer
- Between 18 and 80 years old
- Karnofsky Performance Status (KPS) ≥ 70%，Guaranteed treatment for 3 months
- Normal functions of heart, lung and kidney
- Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥ 1,500/mm^3 、Platelet count ≥ 100,000/mm^3， start the treatment within 14 days after these results meet the requirements
- A life expectancy > 3 months
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- Informed consent signed
- HLA-haplotype-matched immediate family health donors who have been confirmed by laboratory HLA genotypes
- Interval the last anti-tumor treatment for more than 3 months
Who cannot join
- Highly allergic or people with severe allergies
- Brain metastasis or Primary central nervous system malignancy
- Suffer from clinical illnesses that affect clinical trials, including but not limited to： Uncontrollable diabetes；active infectious disease or uncontrollable infection; acute and chronic liver disease; confirmation of HIV infection; uncontrollable hypertension, symptomatic congestive heart-failure, unstable angina pectoris, and myocardial infarction, uncontrollable arrhythmia over the last 6 months.
- Combined heart, lung, kidney and other vital organs dysfunction
- A serious coagulation dysfunction, a clear history of other tumors
- Pregnant and lactating women
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- Mental illness, affecting the compliance of clinical trials
- The patient will participate in other trials within 10 days prior to the trial or While participating in other tests
- Patients underwent weight loss by 10% and above within 6 weeks before the start of the trial
- Neutrophils<500mm^3 or Platelet count<50,000/mm^3
- Need to drive and manipulate the machine during the trial
- Donor's Inclusion Criteria:
- First-degree relatives of patients
- Age<55 years old
- Normal functions of heart, lung and kidney
- Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥ 1,500/mm^3 、Platelet count ≥ 100,000/mm^3、WBC≥ 3000/mm^3， start collecting stem cells within 14 days after these results meet the requirements
- Informed consent signed
- Donor's exclusion Criteria:
- Highly allergic or people with severe allergies
- The person who have history of atherosclerosis, venous thrombosis or autoimmune disease
- A serious coagulation dysfunction, a clear history of other tumors
- Infectious disease or carriers
- Pregnant and lactating women
- Mental illness, affecting the compliance of clinical trials
- WBC<4000/mm^3、PLT<70*10^9/L
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 30000
About this study
Official title: Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation has been successfully used for the treatment of hematopoietic malignancy. In recent years, non-myeloablative hematopoietic stem cell transplantation (NST) has been introduced to treat solid tumors due to the Graft-versus tumor effect. In this study, the investigators try to evaluate the safety and efficacy of NST in the treatment of unresectable pancreatic cancer patients.
- Being tested
- Gemcitabine, GPBSC
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Chemotherapy: Gemcitabine is administered Intravenous injection once a week，at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.
GPBSCOther
immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.
| Study group | Role | What they receive |
|---|---|---|
| GEM plus GPBSC | Experimental | Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg Receives: Drug: Gemcitabine; Other: GPBSC |
| Gemcitabine | Other | Not described Receives: Drug: Gemcitabine |
| GPBSC | Other | Not described Receives: Other: GPBSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival will be measured at 3 months after transplant.
Measured: 3 months
Secondary outcomes (5)
Progression free survival（PFS）
Measured: 3 months
Overall survival (OS)
Measured: 3 months
Response rate
Measured: 3 months
Adverse Events
Measured: 3 months
Karnofsky Performance Status（KPS）
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study startApr 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, MD, PHD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236883
- Sponsor's protocol ID
- NST-01
- Acronym
- HST
- Status last verified
- Apr 2017
- First submitted
- 12 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03236883
- Acronym / sponsor ID
- HST / NST-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 2 Aug 2017 (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.
To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.
Detailed description
Allogeneic hematopoietic stem cell transplantation has been successfully used for the treatment of hematopoietic malignancy. In recent years, non-myeloablative hematopoietic stem cell transplantation (NST) has been introduced to treat solid tumors due to the Graft-versus tumor effect. In this study, the investigators try to evaluate the safety and efficacy of NST in the treatment of unresectable pancreatic cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GEM plus GPBSC | Experimental | Drug: Gemcitabine, Other: GPBSCGemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg |
| Gemcitabine | Other | Drug: Gemcitabine |
| GPBSC | Other | Other: GPBSC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PET-CT/EUS-FNA cytologically confirmed stage III -Ⅳ of pancreatic cancer
- Between 18 and 80 years old
- Karnofsky Performance Status (KPS) ≥ 70%，Guaranteed treatment for 3 months
- Normal functions of heart, lung and kidney
- Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL、 Absolute granulocyte count ≥ 1,500/mm^3 、Platelet count ≥ 100,000/mm^3， start the treatment within 14 days after these results meet the requirements
Key exclusion criteria (25 listed)
- Highly allergic or people with severe allergies
- Brain metastasis or Primary central nervous system malignancy
- Suffer from clinical illnesses that affect clinical trials, including but not limited to： Uncontrollable diabetes；active infectious disease or uncontrollable infection; acute and chronic liver disease; confirmation of HIV infection; uncontrollable hypertension, symptomatic congestive heart-failure, unstable angina pectoris, and myocardial infarction, uncontrollable arrhythmia over the last 6 months.
- Combined heart, lung, kidney and other vital organs dysfunction
- A serious coagulation dysfunction, a clear history of other tumors
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 |
|---|---|---|
| GemcitabineChemotherapy: Gemcitabine is administered Intravenous injection once a week，at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all. | Drug | GEM plus GPBSC, Gemcitabine |
| GPBSCimmunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all. | Other | GEM plus GPBSC, GPBSC |
Primary outcome
Survival
Time frame: 3 months
Survival will be measured at 3 months after transplant.
5 secondary outcomes
Progression free survival（PFS）
Time frame: 3 months
Overall survival (OS)
Time frame: 3 months
Response rate
Time frame: 3 months
Adverse Events
Time frame: 3 months
Karnofsky Performance Status（KPS）
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
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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.
Jihui Hao, MD, PHD principal investigator
Tianjin Medical University Cancer Institute and 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 study testing Gemcitabine and GPBSC in people with Pancreatic Cancer Stage III and Pancreatic Cancer Stage IV, run by Tianjin Medical University Cancer Institute and 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 9 inclusion and 25 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 2 Aug 2017. 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 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.
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 He Ren, MD,PHD (022-23340123-3073, renhe@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 3 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 2 Aug 2017.