Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.
Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib | Experimental | In this arm, patients will receive a daily oral treatment with Apatinib 500mg. |
|
| Capecitabine | Experimental | In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks. |
|
| Observation | No Intervention | In this arm, no additional treatment will be given, and patients will be followed up at regular time |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib: 500mg qd po, q4w |
| |
| Capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is calculated from the time of randmization to disease progression or death whichever happen first | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is calculated from the time of randmization to death | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) | we will use EORTC QLQ-C30 to evaluate QoL. | six weeks |
| Adverse Events | we will use CTC AE4.0 to evaluate adverse events. |
Inclusion Criteria:
Exclusion Criteria:
no younger than 18 year-old
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Capecitabine: 1000mg/m2 bid po, d1-14, q3w |
|
| six weeks |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D013272 | Stomach Diseases |
| D004067 | Digestive System Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C553458 | apatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided