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

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.

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.

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