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In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group.
The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCS | Experimental | nimotuzumab plus cisplatin and S-1 |
|
| CS | Active Comparator | cisplatin and S-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nimotuzumab | Drug | nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression as measured by RECIST 1.1 | 5 years | |
| Progression-free survival measured by RECIST 1.1 | 5 years | |
| Treatment safety and toxicity as measured by Common Toxicity Criteria for Adverse Effects(CTCAE 3.0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yihebali Chi, Doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | 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 |
|---|---|
| C501466 | nimotuzumab |
| D002945 | Cisplatin |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| cisplatin |
| Drug |
cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks |
|
| S-1 | Drug | S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ; |
|
| 5 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |