A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab Nab-Paclitaxel S-1
- Conditions
- Gastric Cancer
- Sponsor
- Hebei Medical University
- Enrollment
- 30
- Primary Endpoint
- R0-resection rate
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.
Investigators
Qun Zhao
Principal Investigator
Hebei Medical University
Eligibility Criteria
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%;
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.
Arms & Interventions
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.
Intervention: Camrelizumab Nab-Paclitaxel S-1
Outcomes
Primary Outcomes
R0-resection rate
Time Frame: within 3 weeks after surgery
There was no residual by the microscope
Conversion to negative rate
Time Frame: within 3 weeks after surgery
Exfoliative cytology positive gastric cancer conversion to negative rate
Secondary Outcomes
- Overall survival (OS)(3years)
- Objective response rate (ORR)(tumor assessment every 6 weeks since the treatment began，up to 3years)
- Tumor regression grade (TRG)(within 3 weeks after surgery)
- Progression free survival (PFS)(3years)
- Disease control rate (DCR)(tumor assessment every 6 weeks since the treatment began，up to 3years)
- Adverse events(3 years)