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Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT04879654•Eye & ENT Hospital of Fudan University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

May 1, 2021

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

March 5, 2024

Enrollment

ESTIMATED participants

Conditions

Malignant MelanomaSinonasal Melanoma

Interventions

endoscopic surgery

PROCEDURE

Contacts

Xiaole Song, MD

CONTACT

15821388769 jxfxsxl@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

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