The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

Study Overview
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Brief Summary
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To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery

Official Title
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The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Neoadjuvant Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1). Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved. No bulky lymph node metastasis is detected by abdominal CT. No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT. No clinically apparent distant metastasis. Karnofsky performance status ≥70%. Sufficient oral intake. No previous treatment with chemotherapy or radiation therapy for any tumors. No previous surgery for the present disease. Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0*104/mm3 (5.0*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl No need for emergency surgery due to bleeding or perforation of the primary tumor. No mechanical obstruction. Written informed consent. Exclusion Criteria: Past history of upper abdominal surgery. Past history of surgery for the gastrointestinal tract. Body mass index exceeding 30 kg/m2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Locally advanced gastric cancer<br>Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy | Procedure: Neoadjuvant Therapy<br>* Drug: Camrelizumab 200mg,d1，Repeat every 21 days for 3 courses； Oxaliplatin 130mg/m² ,d1;S-1 40-60mg,Bid, d1-14; S-1: bsa<1.25m2,40mg/time，twice a day；bsa1.25 1.5m2，50mg/time，twice a day；bsa≥1.5m2,60mg/次，twice a day，d1-d14； Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR rate | Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission. | 30 days | 
| PFS | Defined as the time from the start of randomization to the progression of the disease or the death of the patient. | 3 years | 
| OS | Defined as the time between the beginning of randomization and the death of the patient for any reason. | 3 years | 
| postoperative complication | Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system. | Up to 30 days post-operative | 
| operative mortality | Defined as death of any cause within 30 days of surgery. | Up to 30 days post-operative |