- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03236883
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer (HST)
28. juli 2017 opdateret af: Tianjin Medical University Cancer Institute and Hospital
Phase I Study of Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Pancreatic Cancer
To evaluate the safety and efficacy of non-myeloablative hematopoietic stem cell transplantation in the treatment of pancreatic cancer.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Tianjin
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Tianjin, Tianjin, Kina, 30000
- Rekruttering
- Tianjin Medical University Cancer Institute and Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: GEM plus GPBSC
Gemcitabine chemotherapy with mobilized GPBSC infusion:Gemcitabine 1000mg/m2 +GPBSC(2-3)*10^8/kg
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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.
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.
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Andet: Gemcitabine
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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.
|
|
Andet: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Survival
Tidsramme: 3 months
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Survival will be measured at 3 months after transplant.
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3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Uønskede hændelser
Tidsramme: 3 måneder
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3 måneder
|
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Samlet overlevelse (OS)
Tidsramme: 3 måneder
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3 måneder
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Svarprocent
Tidsramme: 3 måneder
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3 måneder
|
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Progression free survival(PFS)
Tidsramme: 3 months
|
3 months
|
|
Karnofsky Performance Status(KPS)
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jihui Hao, MD, PHD, Tianjin Medical University Cancer Institute and Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2016
Primær færdiggørelse (Forventet)
1. april 2019
Studieafslutning (Forventet)
1. april 2019
Datoer for studieregistrering
Først indsendt
12. juli 2017
Først indsendt, der opfyldte QC-kriterier
28. juli 2017
Først opslået (Faktiske)
2. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Sygdomme i det endokrine system
- Neoplasmer i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Bugspytkirtel neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
Andre undersøgelses-id-numre
- NST-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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