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

Pancreatic Cancer Stage IV Clinical Trial

— HST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03236883
• Other study ID #: NST-01
• Status: Recruiting
• Phase: Phase 1
• First received: July 12, 2017
• Last updated: July 28, 2017
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: He Ren, MD,PHD
• Phone: 022-23340123-3073
• Email: renhe[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• PET-CT/EUS-FNA cytologically confirmed stage III -? 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

Related Conditions & MeSH terms

• Pancreatic Cancer Stage III
• Pancreatic Cancer Stage IV
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
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.

Other:
• GPBSC
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.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival will be measured at 3 months after transplant.	3 months
Secondary	Progression free survival(PFS)		3 months
Secondary	Overall survival (OS)		3 months
Secondary	Response rate		3 months
Secondary	Adverse Events		3 months
Secondary	Karnofsky Performance Status(KPS)		3 months