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This trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
One hundred patients with locally advanced or metastatic gastric adenocarcinoma or gastric esophageal junction adenocarcinoma will be randomly assigned to the test group or the control group. All patients will receive Docetaxel for injection (Albumin-bound) or Taxotere for treatment until disease progression. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel for Injection (Albumin-bound) | Experimental | Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks. |
|
| Taxotere | Active Comparator | Taxotere will be administrated by intravenous infusion once every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel for injection (Albumin-bound) | Drug | Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival (PFS) | The duration is from the randomized time to disease progression or death due to any reason. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The primary endpoint is objective response rate,which equals CR+PR. | Up to approximately 2 years |
| Disease control rate (DCR) | The primary endpoint is Disease Control rate,which equals CR+PR+SD. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of docetaxel (free and total) | At the end of Cycle 1(each cycle is 21 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu | Contact | +86-20-87343468 | xurh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ethics Committee of Sun-Yat-Sen University Cancer Center | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D007267 | Injections |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Taxotere | Drug | Taxotere, by intravenous infusion, every 3 weeks. |
|
| Up to approximately 2 years |
| Duration of Response (DoR) | The time from the first assessment of tumor as CR or PR to the first assessment as PD or death from any cause | Up to approximately 2 years |
| Overall survival (OS) | OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost | Up to approximately 2 years |
| Incidence of AE and SAE | Up to approximately 2 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |