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This is a prospective, single-armed, open label study on the efficacy and safety of sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the phase one step of the trial, receiving IP therpy. Once the IP therapy has been finished without disease progression or progression occurs during the treatment, the patient will enter the phase two step of the trial, receiving octreotide treatment. The primary endpoint is progression free survival in the two steps respectively and secondary endpoint is disease control rate, overall survival and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | This is a single arm trial. The patient will enter phase one and will continue to phase two once the disease progresses in phase one or the phase one has been completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan combined with cisplatin, octreotide lar | Drug | Phase 1 irinotecan 180mg/m^2,ivgtt,90min,D1 Cisplatin 50 mg/m^2,ivgtt,120min,D1(with hydration) Phase 2 Octreotide 0.1mg,ih,q8h,D1-14 Octreotide lar 20mg,deep i.m,D8, |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival for Irinotecan plus cisplatin and octreotide | The primary objective is to investigate the overall progression free suvival for irinotecan plus cisplatin and octretide. The respective PFS of the two treatment steps will also be investigated. The result will be compared with the history treatment outcomes for patients of poorly differentiated neuroendocrine carcinoma. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | The second objective includes the disease control rate of irinotecan plus cisplatin and octretide theray. | 2 years |
| Overall survival | The secondary objective includes the investigation of the overall survival for the patients receiving the sequential treatment of irinotecan plus cisplatin and octretide. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tumor Hospital | Beijing | Beijing Municipality | China |
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| 3 years |
| Safety | The secondary objective also includes the investigation on the safety profiles of the two interventions, irinotecan plus cisplatin treatment and octretide. The safety profile will be described using incidence of AEs and SAEs, using CTCAE criteria | 3 years |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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