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

NCT ID: NCT03236883

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

Pancreatic Cancer Stage III; Pancreatic Cancer Stage IV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GEM plus GPBSC

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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.

GPBSC

Intervention Type: OTHER

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.

Gemcitabine

Group Type: OTHER

Gemcitabine

Intervention Type: DRUG

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.

GPBSC

Group Type: OTHER

GPBSC

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

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

• 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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jihui Hao, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Ren, MD,PHD

Role: CONTACT

renhe@tjmuch.com

022-23340123-3073

Other Identifiers

NST-01

Identifier Type: -

Identifier Source: org_study_id