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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting
This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage Ⅲ gastric cancer as adjuvant setting. The primary endpoint is the 3-year diseases-free survival (DFS) rate. The secondary endpoints are the overall survival (OS) and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AS | Experimental | Arm A:nab paclitaxel (120mg/m2;iv;d1,8)+S-1 (<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid)Q3W;up to eight cycles |
|
| XELOX | Active Comparator | Arm B:Capetabine(1000 mg/m2 po, d1-14 bid )+ Oxaliplatin(130mg/m2 , iv, d1)Q3W;up to eight cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab paclitaxel | Drug | nab paclitaxel (120mg/m2;iv;d1,8) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 years Diseases-free Survival rate(3 years-DFS) | DFS is defined as time from the date of inclusion up to the date of disease progression or death | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival is defined as time from the start of treatment until death due to any reason. | up to 3 years |
| Safety as measured by number and grade of adverse events | Summary adverse events according to NCI-CTCAE 5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng xiangdong, PhD | Contact | 0571-88128041 | Chengxd516@126.com | |
| Yu pengfei, PhD | Contact | 0571-88128041 | ypfzmu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng xiangdong, PhD | Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences | Recruiting | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33435909 | Derived | Cheng X, Wu D, Xu N, Chen L, Yan Z, Chen P, Zhou L, Yu J, Cui J, Li W, Wang C, Feng W, Wei Y, Yu P, Du Y, Ying J, Xu Z, Yang L, Zhang Y. Adjuvant albumin-bound paclitaxel combined with S-1 vs. oxaliplatin combined with capecitabine after D2 gastrectomy in patients with stage III gastric adenocarcinoma: a phase III multicenter, open-label, randomized controlled clinical trial protocol. BMC Cancer. 2021 Jan 12;21(1):56. doi: 10.1186/s12885-020-07772-7. |
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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 |
|---|---|
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D005641 | Tegafur |
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
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| Tegafur | Drug | S-1 (<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid) |
|
|
| Oxaliplatin | Drug | Oxaliplatin(130mg/m2 , iv, d1) |
|
| Capecitabine | Drug | Capetabine(1000 mg/m2 po, d1-14 bid ) |
|
| up to 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |