NCT03236883
Unknown
Phase 1
Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country30 target enrollmentApril 2016
DrugsGemcitabine
Overview
- Phase
- Phase 1
- Intervention
- Gemcitabine
- Conditions
- Pancreatic Cancer Stage III
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Survival
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
GEM plus GPBSC
Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)\*10\^8/kg
Intervention: Gemcitabine
GEM plus GPBSC
Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)\*10\^8/kg
Intervention: GPBSC
Gemcitabine
Intervention: Gemcitabine
GPBSC
Intervention: GPBSC
Outcomes
Primary Outcomes
Survival
Time Frame: 3 months
Survival will be measured at 3 months after transplant.
Secondary Outcomes
- 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)
Study Sites (1)
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