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| Name | Class |
|---|---|
| START Shanghai | UNKNOWN |
| Beijing Bozhiyin T&S Co., Ltd. | INDUSTRY |
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The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant HSV-1 Injection | Experimental | Intratumoral injection Single dose: 4 groups -- 106 pfu, 107 pfu, 108 pfu and 4×108 pfu Multiple dose (three injections, every 2 weeks): 2 groups -- 108, 108, 108pfu and 4×108, 4×108, 4×108pfu Continuous treatment: Upon 4 weeks follow-up after administration, if the investigator deems that continuous treatment will benefit subjects, continuous intratumoral injection may be given, and the interval between each injection will be 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant hGM-CSF Herpes Simplex Virus Injection | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03 | 28 days after the last administration |
| Measure | Description | Time Frame |
|---|---|---|
| Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010 | 28 days after the last administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD | Fudan University | Principal Investigator |
| Jun Ren, MD | Beijing Shijitan Hospital,CMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital,CMU | Beijing | Beijing Municipality | 100038 | China | ||
| Fudan University Shanghai Cancer Center |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |