Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GZH-001 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance. |
|
| B | Placebo Comparator | Observation until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug |
| ||
| Oxaliplatin and Capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | from the date of randomization until death from any cause or up to 1 year | |
| adverse events (AE) | from date of randomization to 28 days after the last chemo dosage | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengya Zhou, bachelor | Contact | 86 13980972569 | yaya713913@126.com |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial. |
|
| health-related quality of life (HRQOL |
| evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |