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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Qun Zhao, Professor
- Telefoonnummer: 13930162111
- E-mail: Zhaoqun516@126.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
R0-resectiepercentage
Tijdsspanne: binnen 3 weken na de operatie
|
Er was geen residu door de microscoop
|
binnen 3 weken na de operatie
|
|
Conversion to negative rate
Tijdsspanne: within 3 weeks after surgery
|
Exfoliative cytology positive gastric cancer conversion to negative rate
|
within 3 weeks after surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall survival (OS)
Tijdsspanne: 3years
|
Baseline to measured date of death from any cause
|
3years
|
|
Progression free survival (PFS)
Tijdsspanne: 3years
|
Baseline to measured date of progression or death from any cause
|
3years
|
|
Objective response rate (ORR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: within 3 weeks after surgery
|
TRG included four grades: Grade 0-3
|
within 3 weeks after surgery
|
|
Adverse events
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Maagneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Paclitaxel
Andere studie-ID-nummers
- HRCG-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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