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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Second Affiliated Hospital of Zhengzhou University | OTHER |
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Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.
This is a prospective, randomized, multi-center, controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide and CPT-11 in advanced gastric cancer. A total of 900 patients are planned to be enrolled into the study. Patients with diagnosis of advanced gastric cancer will be randomized into two groups, and be treated with thalidomide+ CPT-11 or CPT-11, respectively. The primary end point is time to progression (TTP), and the secondary end points include efficacy, overall survival (OS) and the occurrence of delayed diarrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (thalidomide+CPT-11) | Experimental | Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles ,and oral thalidomide 100 mg/d qn. Maintenance therapy with thalidomide in the same dose is performed until disease progression. |
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| Arm B (CPT-11) | Experimental | Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug | Given orally |
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| Measure | Description | Time Frame |
|---|---|---|
| time to progression(TTP) | up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate (CRR) for advanced gastric cancer | up to 2 months | |
| overall survival (OS) | up to 2 months |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Jufeng | Contact | 13783583966 | 13783583966@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Jufeng | Henan Cancer Hospital | Study Chair |
| Qin Yanru | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Zhou Yun |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | 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 |
|---|---|
| D013792 | Thalidomide |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| The First Affiliated Hospital of Henan University of Science and Technology |
| OTHER |
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| CPT-11 | Drug | Given Ivgtt |
|
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| Henan Provincial People's Hospital |
| Principal Investigator |
| Zhang Zhongmian | Second Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Guo Yanzhen | The First Affiliated Hospital of Henan University of Science and Technology | Principal Investigator |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |