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This study is single-arm, none randomized, open label, two-dose-cohorts, single center clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned surgical excision of the lesion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oshadi D and Oshadi R | Experimental | Anti tumor agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oshadi D & Oshadi R | Drug | Anti tumor agents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events occurence | treatment end (day 60 or 90) |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint of this study is Overall Response Rate (ORR) | treatment end (day 60 or 90) |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the duration of treatment to achieve response | To estimate the duration of treatment needed to achieve response | 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lior Heller, Prof. | Assaf Harofeh Medical Center, Zrifin, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf-Harofeh Medical Center | Zrifin | Israel |
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