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TSA-DC Vaccine in Treating Patients With Gastrointestinal Solid Tumor

11. august 2017 oppdatert av: BGI, China

Study of DC Vaccine Loaded Tumor Specific Antigen in Treating Patients With Gastrointestinal Solid Tumor

The goal of this study is to learn about the safety and tolerance of autologous TSA-DC cell and evaluate the efficacy and feasibility of the cell therapy compared to the patients' past standard regimen. 20 gastrointestinal solid tumors subjects failed from at least one systemic therapy will be enrolled into the trial and receive a succession of treatment of TSA-DC vaccine.

Studieoversikt

Detaljert beskrivelse

20 gastrointestinal solid tumor subjects failed from at least one systemic therapy will be enrolled into the trial .Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1, 3, 5, 11,17,23,35,47. Before the first cell infusion, the subjects should undergo a non-myeloablative chemotherapy regimen of Cyclophosphamide 300mg/m2 iv. Radiologic tumor assessment will be repeated every 8 weeks during treatment, until time of progression. Treatment will continue until disease progression, intolerance of toxic , withdrawal from the study, study completion, or study termination.

Studietype

Intervensjonell

Registrering (Forventet)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Be ≥18 and ≤75,no gender based;
  2. Expression of HLA-A0201/1101/2402;
  3. Histopathologic documentation of gastrointestinal solid tumors(stomach cancer or colorectal cancer ) concurrent with the diagnosis of metastatic disease, and the tumor is Measurable;
  4. Patients must have adequate tissue (fresh or paraffin block) for DNA extraction, which is used for gene sequencing, and prognoses the tumor specific antigen in turn,can predict to have new tumor antigens with high affinity for MHC molecules;
  5. Failure in conventional treatment, or though benefit from chemotherapy the patient can't tolerant subjectively;
  6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 and an anticipate life expectancy of at least three months,be cooperate to adverse reactions monitoring and therapeutic evaluation of the treatment;
  7. Participants of child-bearing potential must agree to use adequate contraceptive methods up to 12 months after the pretreatment;
  8. Serology:Seronegative for HIV antibody,seronegative for hepatitis C antibody. Hematology:Absolute neutrophil count ≥ 1000/mm(3) without the support of filgrastim ,WBC ≥ 3000/mm(3),lymphocyte count ≥ 800/mm(3),Platelet count ≥ 100,000/mm(3),Hemoglobin ≥ 9.0 g/dl Chemistry:Serum ALT/AST ≤ 2.5 times the upper limit of normal,Serum Creatinine ≤1.6 mg/dl,Total bilirubin < 1.5 mg/dl, except in patients with Gilbert s Syndrome who must have a total bilirubin < 3.0 mg/dl;
  9. Patients or their legal representatives are willing and able to understand and written informed consent form for the trial;

Exclusion Criteria:

  1. Is pregnant or breastfeeding,or expecting to conceive;
  2. Have a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
  3. Suffered grade 3-4 major organ immune-related adverse events after anti-PD1/PDL1 antibody treatment.
  4. Once received allogeneic organ transplantation (including bone marrow transplantation and peripheral stem cell transplantation, except for corneal transplantation);
  5. Have clinical symptoms of central nervous system metastases;
  6. Have used a large number of glucocorticoids or other immunosuppressive agents within 4 weeks;
  7. Have any active autoimmune disease ;
  8. Be in active infection or undergo an unknown cause fever> 38.5 ℃ during screening or before the first administration(except tumor fever which evaluated by the researchers have no effect to enrollment );
  9. Received chemotherapy or small molecule targeted drug therapy in 4 weeks prior to chemotherapy pretreatment;
  10. Received any antibody drug therapy (including PD-1 and CTLA-4) within 6 weeks before the treatment period;
  11. Severe liver and kidney dysfunction or uncontrollable diabetes, hypertension and other chronic systemic diseases; severe coagulation disorders, mental illness, cardiopulmonary disease,hydrothorax or ascites;

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experimental

Drug:Cyclophosphamide

Biological/Vaccine:Tumor Specific Antigen-loaded Dendritic Cells

Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1,3,5,11,17,23,35,47.
Andre navn:
  • TSA-DC vaccine
300 mg/m2 by vein before the first cell infusion.
Andre navn:
  • Cytoksan

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
safety endpoint
Tidsramme: one year
All the local or systemic reactions, adverse events and serious adverse events that occurred between the first and the second TSA-DC administration.
one year
Overall Response Rate
Tidsramme: one year
Percentage of cases whose tumor shrinks to a certain extent and remains for a certain period of time.
one year
Proportion of the number of cases that has produced tumor-specific antigen-specific T cells in peripheral blood.
Tidsramme: one year
one year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary safety endpoint
Tidsramme: one year
All local or systemic reactions, adverse events and serious adverse events that occurred from entering the trial until 30 days after the last treatment;
one year
Six month DCR(CRR+PRR+SDR)
Tidsramme: 6 month
Percentage of cases with no progression (CR + PR + SD) in 6 months after initiation of treatment;
6 month
Duration of Response(DOR)
Tidsramme: one year
The time from the first tumor evaluation of remission(CR + PR ) till the first assessment of PD or the end the study.
one year
Progression-free survival(PFS)
Tidsramme: one year
The time from entering the trial till the subject has been diagnosed with progression of disease or died.
one year
rate of 12-month survival
Tidsramme: one year
Percentage of cases with 12 months survival after initiation of treatment in all the subjects;
one year
Quality score of life improvement
Tidsramme: one year
Evaluated by the questionnaire of life improvement quality collected from the screening to treatment periods.
one year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: ZengQing Guo, Professor, Fujian Cancer Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. desember 2017

Primær fullføring (Forventet)

1. desember 2018

Studiet fullført (Forventet)

1. juni 2019

Datoer for studieregistrering

Først innsendt

11. juni 2017

Først innsendt som oppfylte QC-kriteriene

12. juni 2017

Først lagt ut (Faktiske)

14. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2017

Sist bekreftet

1. august 2017

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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