- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Qun Zhao, Professor
- Numéro de téléphone: 13930162111
- E-mail: Zhaoqun516@126.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Taux de résection R0
Délai: dans les 3 semaines après la chirurgie
|
Il n'y avait pas de résidu au microscope
|
dans les 3 semaines après la chirurgie
|
|
Conversion to negative rate
Délai: within 3 weeks after surgery
|
Exfoliative cytology positive gastric cancer conversion to negative rate
|
within 3 weeks after surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall survival (OS)
Délai: 3years
|
Baseline to measured date of death from any cause
|
3years
|
|
Progression free survival (PFS)
Délai: 3years
|
Baseline to measured date of progression or death from any cause
|
3years
|
|
Objective response rate (ORR)
Délai: 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)
Délai: 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)
Délai: within 3 weeks after surgery
|
TRG included four grades: Grade 0-3
|
within 3 weeks after surgery
|
|
Adverse events
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs de l'estomac
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Paclitaxel
Autres numéros d'identification d'étude
- HRCG-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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