- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02862613
Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
Objectives:
To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 201318
- Rekruttering
- Shanghai International Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 18~65 years old, male or female;
- Life expectancy≥6 months;
- ECOG score: 0-3;
- Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
- Enough venous channel, no other contraindications to the separation and collection of white blood cells;
- Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
- Signed informed consent;
- Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
Exclusion Criteria:
- Expected Overall survival < 3 months;
- The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus;
- Liver function is Childs Pugh C;
- Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney;
- Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Transcatheter Arterial Chemoembolization
patients will receive MMC,EADM hepatic arterial infusion,6 cycles.
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Lipiodol 10-20ml,MMC 8~10mg,EADM20~40mg.According to tumor area of maximum diameter,0.1~0.2ml/cm2
Hepatic arterial infusion.
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Eksperimentell: Precision Cells
Precision Cells combined with Transcatheter Arterial Chemoembolization: Transcatheter Arterial Chemoembolization: patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells:After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment |
Lipiodol 10-20ml,MMC 8~10mg,EADM20~40mg.According to tumor area of maximum diameter,0.1~0.2ml/cm2
Hepatic arterial infusion.
DC cell suspension (1×107 DC+ physiological saline + 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Total overlevelse
Tidsramme: 2 år
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2 år
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Fremskrittsfri overlevelse
Tidsramme: 2 år
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2 år
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Livskvalitet
Tidsramme: 2 år
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Spørreskjema vil bli brukt.
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2 år
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SIMC-20160106
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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