Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV
Conditions
Brief summary
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.
Interventions
DRUGGemcitabine
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.
OTHERGPBSC
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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 3 months | Survival will be measured at 3 months after transplant. |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactHe Ren, MD,PHD
Outcome results
None listed