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This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1 | Experimental |
| |
| SHR-1701 and CAPOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 | Drug | SHR-1701, 1800mg, Q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year overall survival rate | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion surgery rate | Up to 4 weeks after completion of surgery | |
| R0 resection rate | Up to 4 weeks after completion of surgery | |
| Pathological complete response(pCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanan Zheng | Contact | +8613636404065 | ianzyn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanan Zheng | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | China | |||
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine |
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| Capecitabine | Drug | Capecitabine, Q3W |
|
| S-1 | Drug | S-1, Q3W |
|
| Paclitaxel | Drug | Paclitaxel,Q3W |
|
| Oxaliplatin | Drug | Oxaliplatin, Q3W |
|
| Up to 4 weeks after completion of surgery |
| Tumor regression grade | Up to 4 weeks after completion of surgery |
| Event free survival (EFS) | Up to 2 years |
| DFS | Disease-free survival (DFS) | Up to 2 years |
| Overall survival(OS) | Up to 3 years |
| AEs | Up to approximately 18 months |
| Shanghai |
| China |
|
| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| D000069287 | Capecitabine |
| C079198 | S 1 (combination) |
| D017239 | Paclitaxel |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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