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

Eye & ENT Hospital of Fudan University1 site in 1 country45 target enrollmentMay 1, 2021

ConditionsMalignant Melanoma Sinonasal Melanoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Malignant Melanoma
Sponsor: Eye & ENT Hospital of Fudan University
Enrollment: 45
Locations: 1
Primary Endpoint: Overall survival
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2021

End Date

May 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eye & ENT Hospital of Fudan University

Responsible Party

Principal Investigator

Hongmeng Yu

MD,PhD

Eye & ENT Hospital of Fudan University

Eligibility Criteria

Inclusion Criteria

•1.Pathologically diagnosed as sinonasal malignant mucosal melanoma, locally resectable and no contraindication for surgery or radiation. 2.T3 and T
•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

•Patients who refused to sign informed consent.
•Have received radioactive seed implantation in the treatment area.
•Suffer from uncontrolled disease which could interfere treatment.
•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.).
•The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on. 6.The patients have autoimmune diseases.
•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;
•Severe allergic reaction to other monoclonal antibodies;
•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;
•Live vaccines have been inoculated within 4 weeks before the first administration or during the study period;
•The patient has any situation that may hinder study compliance or the safety during the study period.

Outcomes

Primary Outcomes

Overall survival

Time Frame: 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 Outcomes

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.)