Gastric Cancer
Conditions
Brief summary
To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery
Interventions
PROCEDURENeoadjuvant Therapy
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
Sponsors
The First Hospital of Jilin University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1). 2. Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. 3. The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved. 4. No bulky lymph node metastasis is detected by abdominal CT. 5. 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. 6. No clinically apparent distant metastasis. 7. Karnofsky performance status ≥70%. 8. Sufficient oral intake. 9. No previous treatment with chemotherapy or radiation therapy for any tumors. 10. No previous surgery for the present disease. 11. 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 12. No need for emergency surgery due to bleeding or perforation of the primary tumor. 13. No mechanical obstruction. 14. Written informed consent.
Exclusion criteria
1. Past history of upper abdominal surgery. 2. Past history of surgery for the gastrointestinal tract. 3. Body mass index exceeding 30 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | 30 days | Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 30 days | 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. |
| PFS | 3 years | Defined as the time from the start of randomization to the progression of the disease or the death of the patient. |
| OS | 3 years | Defined as the time between the beginning of randomization and the death of the patient for any reason. |
| postoperative complication | Up to 30 days post-operative | Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system. |
| operative mortality | Up to 30 days post-operative | Defined as death of any cause within 30 days of surgery. |
Countries
China
Contacts
Primary ContactDi Guo
Outcome results
None listed