Status:
UNKNOWN
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Pancreatic Cancer Stage III
Pancreatic Cancer Stage IV
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03236883
Start Date
April 1 2016
End Date
April 1 2019
Last Update
August 2 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 30000