Clinical trial NCT03236883: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
Official title: Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Cancer Stage III
Pancreatic Cancer Stage IV
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Survival
timeFrame: 3 months
Secondary outcomes:
measure: Progression free survival（PFS）
timeFrame: 3 months
measure: Overall survival (OS)
timeFrame: 3 months
measure: Response rate
timeFrame: 3 months
measure: Adverse Events
timeFrame: 3 months
measure: Karnofsky Performance Status（KPS）
timeFrame: 3 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jihui Hao, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: