The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer
Study Details
Study Description
Brief Summary
To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Locally advanced gastric cancer Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy |
Procedure: Neoadjuvant 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
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Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
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The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
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No bulky lymph node metastasis is detected by abdominal CT.
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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.
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No clinically apparent distant metastasis.
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Karnofsky performance status ≥70%.
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Sufficient oral intake.
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No previous treatment with chemotherapy or radiation therapy for any tumors.
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No previous surgery for the present disease.
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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≥10.0104/mm3 (5.0104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
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No need for emergency surgery due to bleeding or perforation of the primary tumor.
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No mechanical obstruction.
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Written informed consent.
Exclusion Criteria:
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Past history of upper abdominal surgery.
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Past history of surgery for the gastrointestinal tract.
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Body mass index exceeding 30 kg/m2.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Hospital of Jilin University | Changchun | Jilin | China | 130000 |
Sponsors and Collaborators
- The First Hospital of Jilin University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STARS-GC02