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Gastric cancer with retroperitoneal lymph node metastasis was considered as unresectable, to improve these patients' prognosis, we designed systematic conversion therapy including immunotherapy and chemoradiotherapy. The purpose of this study is to estimate safety and efficacy of Sintilimab in combination with chemoradiothrapy followed by D2 surgical resection in patients with advanced gastric cancer with retroperitoneal lymph node metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 200 mg Q3W on Day 1 by IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 year Progression Free Survival (PFS) | Approximately 3 years after the first participant is included |
| Measure | Description | Time Frame |
|---|---|---|
| R0 surgical resection percentage | Approximately 2 years after the first participant is included | |
| Operative conversion percentage | Approximately 2 years after the first participant is included | |
| Measure | Description | Time Frame |
|---|---|---|
| Potential biomarker to predict prognosis | PD-L1 CPS, EBV expression, Tumor Mutational Burden(TMB), MSI-H/dMMR | Approximately 4 years after the first participant is included |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changyu He, PhD | Contact | 8618817821339 | hechangyu.2008@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Li, PhD | Ruijin hospital affiliatted to Shanghai Jiaotong University school of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Albumin-Paclitaxel | Drug | 200 mg/m^2 Q3W on Day 1 by IV infusion |
|
| Capecitabine | Drug | 1000 mg/m^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14 |
|
| Oxaliplatin | Drug | 130 mg/m^2 Q3W on Day 1 by IV infusion |
|
| Radiation | Radiation | Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy*25. |
|
| Radical gastric cancer surgery | Procedure | Radical gastric cancer surgery with D2 lymph node dissection |
|
| Overall survival (OS) |
| Approximately 4 years after the first participant is included |
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Approximately 4 years after the first participant is included |
| Percentage of pathologic complete response(pCR) | Approximately 2 years after the first participant is included |
| 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 |
|---|---|
| C000632826 | sintilimab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D011827 | Radiation |
| 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 |
| D055585 | Physical Phenomena |
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