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

NCT ID: NCT04879654

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2026-05-01

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.

Conditions

Malignant Melanoma; Sinonasal Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

endonasal endoscopic surgery with adjuvant therapy

endonasal endoscopic surgery followed by Toripalimab,radiotherapy and/or chemotherapy

Group Type: EXPERIMENTAL

endoscopic surgery

Intervention Type: PROCEDURE

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

Interventions

endoscopic surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

radiotherapy; chemotherapy; Toripalimab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Hongmeng Yu

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongmeng Yu, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Eye&ENT Hospital,Fudan University

Locations

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaole Song, MD

Role: CONTACT

jxfxsxl@163.com

15821388769

Facility Contacts

Li Yan, MD

Role: primary

yanl13@fudan.edu.cn

13761720601

Other Identifiers

SNMM-SA-V1

Identifier Type: -

Identifier Source: org_study_id