Phase II, Single-arm, Prospective Clinical Study of Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of Sinonasal Malignant Mucosal Melanoma（SNMM） After Endoscopic Surgery
Who is this study for? Patients with Melanoma
What treatments are being studied? Endoscopic Surgery
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Eye& ENT Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xiaole Song, MD
jxfxsxl@163.com
15821388769
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 45
Treatments
Experimental: endonasal endoscopic surgery with adjuvant therapy
endonasal endoscopic surgery followed by Toripalimab,radiotherapy and/or chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Eye & ENT Hospital of Fudan University
Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences