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To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with POF | Experimental |
| |
| Tislelizumab combined with mFOLFOX6 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | The length of time from enrollment until the time of progression of disease (PFS, progression-free survival) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate) | every 4 weeks |
| Overall survival | The length of time from enrollment until the time of death (OS, overall survival). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong bo Lin, bachelor | Contact | 13705919382 | 86 | rongbo_lin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong bo Lin, bachelor | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian cancer hospital | Recruiting | Fuzhou | Fujian | 350500 | China |
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| Oxaliplatin injection | Drug | Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days. |
|
| Levo-Leucovorin | Drug | Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days. |
|
| 5-fluorouracil | Drug | 5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days. |
|
| Paclitaxel | Drug | Paclitaxel will be administered on day 1 of each cycle at 135mg/m2 |
|
| 4 years |
| 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 |
|---|---|
| C000707970 | tislelizumab |
| D000077150 | Oxaliplatin |
| D058766 | Levoleucovorin |
| D005472 | Fluorouracil |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002955 | Leucovorin |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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