Malignant Melanoma, Sinonasal Melanoma
Conditions
Brief summary
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.
Interventions
PROCEDUREendoscopic surgery
endoscopic surgery followed by multimodality treatment including radiotherapy,Toripalimab,and/or chemotherapy
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eye & ENT Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of first treatment until the date of death from any cause,through study completion,up to 3 years.] | 3 year Overall Survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 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. | the date of first treatment to the first recording of disease progression or death from any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local progression free survival | From date of first treatment to local failure or date of death from any cause,through study completion,up to 3 years. | the date of first treatment to local failure or death |
| Regional progression free survival | From date of first treatment to regional failure or date of death from any cause, through study completion,up to 3 years. | the date of first treatment to regional failure or death |
| Distant metastasis free survival | From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 3 years.] | the date of first treatment to distant metastasis or death |
| Toxicities | From date of first treatment through study completion,up to 3 years. | Using CTCAE Version5.0 to evaluate |
Countries
China
Contacts
Primary ContactXiaole Song, MD
Outcome results
None listed