Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.

Detailed Description
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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.

Official Title
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Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer

Conditions
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Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV

Intervention / Treatment
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* Drug: Gemcitabine
* Other: GPBSC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEM plus GPBSC<br>Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg | Drug: Gemcitabine<br>* 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.<br>Other: GPBSC<br>* 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.<br>|
| Other: Gemcitabine<br> | Drug: Gemcitabine<br>* 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.<br>|
| Other: GPBSC<br> | Other: GPBSC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival will be measured at 3 months after transplant. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival（PFS） |  | 3 months | 
| Overall survival (OS) |  | 3 months | 
| Response rate |  | 3 months | 
| Adverse Events |  | 3 months | 
| Karnofsky Performance Status（KPS） |  | 3 months |