NCT03236883

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 2, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

July 12, 2017

Last Update Submit

July 28, 2017

Conditions

Pancreatic Cancer Stage IIIPancreatic Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival will be measured at 3 months after transplant.

    3 months

Secondary Outcomes (5)

  • 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

Study Arms (3)

GEM plus GPBSC

EXPERIMENTAL

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

Drug: GemcitabineOther: GPBSC

Gemcitabine

OTHER
Drug: Gemcitabine

GPBSC

OTHER
Other: GPBSC

Interventions

GemcitabineDRUG

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.

GEM plus GPBSCGemcitabine
GPBSCOTHER

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.

GEM plus GPBSCGPBSC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 30000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jihui Hao, MD, PHD

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

He Ren, MD,PHD

CONTACT

022-23340123-3073renhe@tjmuch.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

August 2, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

August 2, 2017

Record last verified: 2017-04

Locations

CN(1)