- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05410847
Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Qun Zhao, Professor
- Telefonnummer: 13930162111
- E-post: Zhaoqun516@126.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- None previous chemotherapy, radiotherapy and other antitumor therapy;
- Age:18 to 70 years old;
- Man or female (except pregnant and lactating women);
- Confirmed to gastric adenocarcinoma and HER2-negative;
- Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
Blood cell count has to meet the following certeria:
WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
Liver/kidney function has to meet the following certeria:
ALT and AST≤2.5×ULN TBIL<1.5×ULN; Serum creatinine ≤1.5×ULN;
- Left ventricular ejection fraction (LVEF) ≥50%;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Participants were willing to join in this study, good adherence and written informed consent.
Exclusion Criteria:
- Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- Patients with other malignant tumors within 5 years;
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
- Distant metastasis;
- It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Patients with severe or uncontrollable mental illness;
- It have serious harm to the patient's safety or affect the patients who have completed the research.
- The researchers think inappropriate.
Studieplan
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
Camrelizumab: 200mg,iv,30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1:According to the body surface area, BSA <1.25m2,40mg bid; 1.25m2≤BSA≤1.5m2,50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator. |
Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
R0-reseksjonsrate
Tidsramme: innen 3 uker etter operasjonen
|
Det var ingen rester ved mikroskopet
|
innen 3 uker etter operasjonen
|
|
Conversion to negative rate
Tidsramme: within 3 weeks after surgery
|
Exfoliative cytology positive gastric cancer conversion to negative rate
|
within 3 weeks after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: 3years
|
Baseline to measured date of death from any cause
|
3years
|
|
Progression free survival (PFS)
Tidsramme: 3years
|
Baseline to measured date of progression or death from any cause
|
3years
|
|
Objective response rate (ORR)
Tidsramme: tumor assessment every 6 weeks since the treatment began,up to 3years
|
Baseline to measured stable disease
|
tumor assessment every 6 weeks since the treatment began,up to 3years
|
|
Disease control rate (DCR)
Tidsramme: tumor assessment every 6 weeks since the treatment began,up to 3years
|
Baseline to measured progressive disease
|
tumor assessment every 6 weeks since the treatment began,up to 3years
|
|
Tumor regression grade (TRG)
Tidsramme: within 3 weeks after surgery
|
TRG included four grades: Grade 0-3
|
within 3 weeks after surgery
|
|
Adverse events
Tidsramme: 3 years
|
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
The number of Participants with adverse events will be recorded at each treatment visit.
|
3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Neoplasmer i magen
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Paklitaksel
Andre studie-ID-numre
- HRCG-001
Plan for individuelle deltakerdata (IPD)
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