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

Primary Purpose

Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
GPBSC
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer Stage III

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

GEM plus GPBSC

Gemcitabine

GPBSC

Arm Description

Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg

Outcomes

Primary Outcome Measures

Survival
Survival will be measured at 3 months after transplant.

Secondary Outcome Measures

Progression free survival(PFS)
Overall survival (OS)
Response rate
Adverse Events
Karnofsky Performance Status(KPS)

Full Information

First Posted
July 12, 2017
Last Updated
July 28, 2017
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03236883
Brief Title
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
Acronym
HST
Official Title
Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Stage III, Pancreatic Cancer Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GEM plus GPBSC
Arm Type
Experimental
Arm Description
Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg
Arm Title
Gemcitabine
Arm Type
Other
Arm Title
GPBSC
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Chemotherapy: Gemcitabine is administered Intravenous injection once a week,at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.
Intervention Type
Other
Intervention Name(s)
GPBSC
Intervention Description
immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.
Primary Outcome Measure Information:
Title
Survival
Description
Survival will be measured at 3 months after transplant.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progression free survival(PFS)
Time Frame
3 months
Title
Overall survival (OS)
Time Frame
3 months
Title
Response rate
Time Frame
3 months
Title
Adverse Events
Time Frame
3 months
Title
Karnofsky Performance Status(KPS)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Ren, MD,PHD
Phone
022-23340123-3073
Email
renhe@tjmuch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihui Hao, MD, PHD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
30000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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