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To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion Therapy | Experimental | Paclitaxel (albumin-bound) +S-1+Oxaliplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 | Drug | Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg,bid, d1-14( BSA<1.25m2,40mg;1.25m2≤BSA≤1.5m2,50mg;BSA>1.5m2,60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Proportion of patients who achieved R0 resection | within 4 weeks following the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | the time from registration to the date of disease progression or death resulting from any cause. | 5 years |
| overall survival (OS) | the time from registration to the date of death resulting from any cause or the last follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiafu ji, MD | Contact | 86-010-88196048 | jiafuj@hotmail.com | |
| Zhaode Bu, MD | Contact | 86-010-88196945 | buzhaode@cjcrcn.org |
| Name | Affiliation | Role |
|---|---|---|
| Jiafu ji, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Zhaode Bu, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 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 |
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| 5 years |
| Adverse Events(AEs) | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. | until 28 days after the last study drug administration |
| 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 |