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The aim of this study is to observe the efficacy and safety of immume checkpoint inhibitor PD-1 SHR1210 combined with Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.
This study is a prospective, one-arm, phase II clinical study to evaluate the safety and efficacy of SHR-1210 in combination with trastuzumab plus oxaliplatin and capecitabine for HER2-positive locally advanced resectable gastric adenocarcinoma and gastroesophageal junction adenocarcinoma during the perioperative treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine | Experimental | trastuzumab + SHR-1210 + capecitabine + oxaliplatin for neoadjuvant chemotherapy 4-cycle.Then D2 radical surgery. The patients continued to receive capecitabine plus oxaliplatin for adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) rate | the rate of no residual tumor cells in both the excised gastric cancer and lymph node (ypT0N0) | up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Defined as the proportion of patients with a documented complete response, and partial response (CR + PR ) | up to 2 year |
| Overall survival(OS) | From date of randomization until the date of death from any cause |
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Inclusion Criteria:
Signed the informed consent form
18-75 years old
Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (cT4 or / and N+M0, MDT believes that perioperative treatment is required):
Have not received cytotoxic chemotherapy or targeted therapy and local tumor resection
HER2 immunohistochemistry 3+ and fluorescence in situ hybridization showed significant amplification
ECOG≤1
Tumor specimens that can be used to detect PD-L1 and MSI status can be provided. Detection of PD-L1 and MSI will be performed after enrollment. This test requires patients to provide paraffin-embedded biopsy specimens.
White blood cells ≥ 4×109/L, platelets without blood transfusion ≥ 100×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L without granulocyte stimulating factor, hemoglobin ≥ 90 g/L
bilirubin ≤ 1.5 times the upper limit of normal value, cereal grass and alanine aminotransferase ≤ 2.5ULN. If there is liver metastasis, the grass and alanine aminotransferase ≤ 5ULN.
serum creatinine ≤ 1.5ULN, or GFR > 45 ml / min
serum albumin ≥ 25 g / L (2.5 g / dL)
INR or APTT ≤ 1.5 ULN
Hepatitis B surface antigen positive patients need to detect hepatitis B DNA virus quantitative detection, only patients below the upper limit of normal detection can be enrolled, and long-term use ofanti-hepatitis B virus drugs
Exclusion Criteria:
25. Participate in other tests within 30 days before the start of the test, or plan to participate in other tests during the test. Accept other experimental drugs within 28 days before the start of the test 26. Women who are pregnant or lactating, or women who are planning to become pregnant within 5 months of the end of treatment. Women of childbearing age are required to undergo a blood pregnancy test within 7 days prior to the start of the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Suxia Luo | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
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|
| up to 2 year |
| safety | adverse events in patients during the neoadjuvant treatment phase | up to 2 year |
| Disease Free Survival(DFS) | The time from the start of randomization to the first tumor recurrence/metastasis or the death of the subject for any reason | up to 2 year |
| 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 |
|---|---|
| D000068878 | Trastuzumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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