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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.
The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| irinotecan and nimotuzumab | Experimental | Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | 180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response | From date of first dose 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 | Overall survival is defined as the time from the date of enrollment to the date of the death from any cause. | 3 years after first enrollment |
| Progression free survival | Progression Free Survival is defined as the time from the date of enrollment to the date of progression or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking cancer hospital | Recruiting | Beijing | Beijing Municipality | 100142 | 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 |
|---|---|
| D000077146 | Irinotecan |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| nimotuzumab | Drug | 400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient |
|
| 3 years after first enrollment |
| Disease control rate | Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Safety | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Potential predictive biomarkers of nimotuzumab | 3 years after first enrollment |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |