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

Phase 1

• Conditions: Pancreatic Cancer Stage III; Pancreatic Cancer Stage IV
• Interventions: Drug: Gemcitabine; Other: GPBSC

• Registration Number: NCT03236883
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Study Start: 2016-04
• Status Verified: 2017-04
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-28
• Last Update Submitted: 2017-07-28
• Study First Posted: 2017-08-02
• Last Update Posted: 2017-08-02
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEM plus GPBSC	GPBSC	Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)\*10\^8/kg
GPBSC	GPBSC	-
GEM plus GPBSC	Gemcitabine	Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)\*10\^8/kg
Gemcitabine	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Survival	3 months	Survival will be measured at 3 months after transplant.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China