Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Camrelizumab Nab-Paclitaxel S-1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Drug: Camrelizumab Nab-Paclitaxel S-1<br>* Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0-resection rate | There was no residual by the microscope | within 3 weeks after surgery | 
| Conversion to negative rate | Exfoliative cytology positive gastric cancer conversion to negative rate | within 3 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Baseline to measured date of death from any cause | 3years | 
| Progression free survival (PFS) | Baseline to measured date of progression or death from any cause | 3years | 
| Objective response rate (ORR) | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began，up to 3years | 
| Disease control rate (DCR) | Baseline to measured progressive disease | tumor assessment every 6 weeks since the treatment began，up to 3years | 
| Tumor regression grade (TRG) | TRG included four grades: Grade 0-3 | within 3 weeks after surgery | 
| Adverse events | 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 |