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Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer
To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced Gastric Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel + S-1 + Oxaliplatin group | Experimental | Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel + S-1 + Oxaliplatin | Drug | Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week. Oxaliplatin: 85 mg/m2, iv, 2h, at D1. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | The sum of complete remission (CR) rate and partial remission (PR) rate. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | 2 years |
| Overall survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiuda Zhao, M.D. | Contact | +8613327661976 | jiudazhao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiuda Zhao, M.D. | Affiliated Hospital of Qinghai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Qinghai University | Recruiting | Xining | Qinghai | 810000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
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From date of enrollment until the date of death from any cause, assessed up to 60 months
| 2 years |
| Disease control rate(DCR) | The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year | 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |