RecruitingPhase 2NCT04879654

Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery

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


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

45 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding toripalimab (a PD-1 immunotherapy drug) to standard radiation therapy and chemotherapy improves outcomes in patients with sinonasal mucosal melanoma (a rare melanoma inside the nasal cavity and sinuses) after surgical removal. This cancer is aggressive and often recurs after surgery alone. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of sinonasal mucosal melanoma - Your cancer is T3 or T4 stage (locally advanced) and can be surgically removed - There is no evidence of cancer spread to distant organs - You have not had prior head and neck radiation or systemic anti-cancer treatment in the past 5 years - Your overall health score is acceptable (ECOG 0–2) and you can tolerate surgery and radiation **You may NOT be eligible if...** - You have active autoimmune disease - You take immunosuppressive drugs or high-dose steroids - You have had prior PD-1/PD-L1 or CTLA-4 immunotherapy - You have severe heart or lung conditions that prevent surgery - You have had another cancer in the past 5 years (except certain skin cancers or in-situ cervical cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREendoscopic surgery

endoscopic surgery followed by multimodality treatment including radiotherapy,Toripalimab,and/or chemotherapy


Locations(1)

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT04879654


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