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This multicenter, randomized study will evaluate the efficacy and safety of apatinib compared to docetaxel treatment in patients with advanced gastric cancer. At the start of the trial, patients will be randomized to one treatment arm: Arm A: apatinib 850mg qd every 3 weeks; Arm B: docetaxel 60mg/m2 every 3 weeks. Tumor assessment will be done every 8 weeks according to RECIST 1.1. The primary endpoint is progression free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib | Experimental | Apatinib 850 mg qd po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Docetaxel | Active Comparator | Docetaxel 60mg/m2 ivgtt every 3 weeks, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug |
| ||
| apatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | defined as the time from randomize to death | Approximately 3 years |
| Objective response rate (ORR) | defined as the rate of complete response and partial response according to RECIST guidelines. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Tianshu, doctor | Contact | +862152303355 | liu.tianshu@zs-hospital.sh.cn | |
| Yu Yiyi, master | Contact | +862164041990 | yu.yiyi@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liu Tianshu, doctor | oncology department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | 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 |
|---|---|
| D000077143 | Docetaxel |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Approximately 1 year |
| Disease control rate(DCR) | defined as the rate of complete response , partial response and stable disease according to RECIST guidelines. | Approximately 1 year |
| Quality of life(QoL) | as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30) | Approximately 3 years |
| Safety (incidence of adverse events) | incidence of adverse events | Approximately 1 year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |