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This is a Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant therapy for locally advanced gastric adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with untreated, operable locally advanced gastric adenocarcinoma | Experimental | Drug: Sintilimal Injection Sintilimal (200mg) will be given i.v. on day 1 of each 3-week cycle. Drug: Capecitabine Capecitabine (1000mg/m2) will be administered orally twice daily on days 1-14 of each 3-week cycle. Drug: Oxaliplatin Oxaliplatin (130mg/m2) will be given i.v. on day 1 of each 3-week cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimal Injection | Drug | Sintilimal (200mg) will be given i.v. on day 1 of each 3-week cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response (pCR) rate | Defined as lack of any viable tumor cells in the surgically removed tumor and lymph node tissues. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) rate | Defined as the proportion of subjects with 10% or less of residual viable tumor cells in the resected primary tumor. | 36 months |
| Disease-free survival (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangpan Li, M.D. | Contact | +86-027-88041911 | rm001227@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiangpan Li | Renmin Hospital of Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430061 | China |
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|
Defined as the time from surgery to the time of first recurrence or death, whichever occurred first.
| 36 months |
| overall survival (OS) | OS is the time from enrollment to death due to any cause. OS is the time from enrollment to death due to any cause. OS is the time from enrollment to death due to any cause.OS is the time from enrollment to death due to any cause. OS is the time from enrollment to death due to any cause. | 36 months |
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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