Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-P/S-1 | Experimental | Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1. |
|
| SOX | Active Comparator | Patients in this arm receive chemotherapy with Oxaliplatin plus S-1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin-bound Paclitaxel plus S-1 | Drug | Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as time from the start of treatment to progression of disease or death. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The rate of participants that achieve either a complete response (CR) or a partial response (PR). | up to 3 years |
| Overall survival (OS) | Overall survival is defined as time from the start of treatment until death due to any reason. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianglin Yuan, MD,PhD | Contact | 8627-83663406 | xlyuan1020@163.com | |
| Hong Qiu, MD,PhD | Contact | 8627-83663406 | tjqiuhong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianglin Yuan, MD,PhD | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35983025 | Derived | Dai YH, Yu XJ, Xu HT, Zhuang L, Zhang MS, Zou YM, Fu Q, Qiu H, Yuan XL. Nab-paclitaxel plus S-1 versus oxaliplatin plus S-1 as first-line treatment in advanced gastric cancer: results of a multicenter, randomized, phase III trial (GAPSO study). Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118020. doi: 10.1177/17588359221118020. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin plus S-1 | Drug | Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days. |
|
| up to 3 years |
| Safety as measured by number and grade of adverse events | Summary adverse events according to NCI-CTCAE 4.03 | up to 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |