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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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Phase II, single-arm, prospective clinical study of Toripalimab(a PD-1 antibody) combined with radiotherapy and chemotherapy in the treatment of sinonasal malignant mucosal melanoma after endoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endonasal endoscopic surgery with adjuvant therapy | Experimental | endonasal endoscopic surgery followed by Toripalimab,radiotherapy and/or chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic surgery | Procedure | endoscopic surgery followed by multimodality treatment including radiotherapy,Toripalimab,and/or chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 year Overall Survival rate | From date of first treatment until the date of death from any cause,through study completion,up to 3 years.] |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | the date of first treatment to the first recording of disease progression or death from any cause. | From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first,through study completion,up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Local progression free survival | the date of first treatment to local failure or death | From date of first treatment to local failure or date of death from any cause,through study completion,up to 3 years. |
| Regional progression free survival |
Inclusion Criteria:
1.Pathologically diagnosed as sinonasal malignant mucosal melanoma, locally resectable and no contraindication for surgery or radiation. 2.T3 and T4. 3.Age ≥18 year-old 4.No distant metastasis 5.No head and neck radiation and systemic anti-tumor therapy performed in the past 5 years. 6.The performance status of the Eastern Cooperative Oncology Group(ECOG) is 0-2 points and surgery after general anesthesia and postoperative radiation could be tolerated. 7.Accepted organ function
Exclusion Criteria:
1. Patients who refused to sign informed consent. 2. Have received radioactive seed implantation in the treatment area. 3. Suffer from uncontrolled disease which could interfere treatment. 4. Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.). 5. The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on. 6.The patients have autoimmune diseases. 7. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before the first administration; 8. Severe allergic reaction to other monoclonal antibodies; 9. Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment; 10. Live vaccines have been inoculated within 4 weeks before the first administration or during the study period; 11. The patient has any situation that may hinder study compliance or the safety during the study period.12. Existence of serious neurological or psychiatric diseases, such as dementia and seizures; 13. Uncontrolled active infection. 14. Pregnant or breastfeeding women. 15. Those who have no personal freedom and independent capacity for civil conduct;p. 16. There are other situations that are not suitable for entry into the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaole Song, MD | Contact | 15821388769 | jxfxsxl@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongmeng Yu, MD,PHD | Eye&ENT Hospital,Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye& ENT Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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|
the date of first treatment to regional failure or death
| From date of first treatment to regional failure or date of death from any cause, through study completion,up to 3 years. |
| Distant metastasis free survival | the date of first treatment to distant metastasis or death | From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 3 years.] |
| Toxicities | Using CTCAE Version5.0 to evaluate | From date of first treatment through study completion,up to 3 years. |
| 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 |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |