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it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab + SOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab + SOX | Drug | Pembrolizumab 200mg, ivdrip, q3w; Oxaliplatin 135mg/m2, ivdrip,q3w; Trastuzumab 40 mg/m2,po bid,d1~d14,q21d. Each cycle consists of three weeks, totaling eight cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the time from the start of surgery to death due to any cause. | 3 years |
| perioperative complications | perioperative complications |
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Inclusion Criteria:
1. Subjects voluntarily join the study and sign an informed consent form; 2. Male or female patients between the ages of 18-75; 3. Adenocarcinoma of the gastric/esophagogastric junction after radical resection was staged at stage IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the following three conditions:
Hemoglobin ≥90g/L;
Absolute neutrophil count ≥1.5×109/ L;
Platelet count ≥100×109/ L;
aspartate or alanine aminotransferase ≤ 2.5 times the upper limit;
alkaline phosphatase ≤ 2.5 times the upper normal limit ; 10. Women of reproductive age who need to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period; For men who agreed to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug.
11. Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenghao Cai | Contact | 17316533505 | c3z2h1@alumni.sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| the time from the start of enrollment to 3 months after surgery |
| Adverse Events | occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment. | the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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