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

Malignant Melanoma Clinical Trial

— SNMM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879654
• Other study ID #: SNMM-SA-V1
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2021
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2024
• Source: Eye & ENT Hospital of Fudan University
• Contact: Xiaole Song, MD
• Phone: 15821388769
• Email: jxfxsxl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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

Locations

Country	Name	City	State
China	Eye& ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local progression free survival	the date of first treatment to local failure or death	From date of first treatment to local failure or date of death from any cause,through study completion,up to 3 years.
Other	Regional progression free survival	the date of first treatment to regional failure or death	From date of first treatment to regional failure or date of death from any cause, through study completion,up to 3 years.
Other	Distant metastasis free survival	the date of first treatment to distant metastasis or death	From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 3 years.]
Other	Toxicities	Using CTCAE Version5.0 to evaluate	From date of first treatment through study completion,up to 3 years.
Primary	Overall survival	3 year Overall Survival rate	From date of first treatment until the date of death from any cause,through study completion,up to 3 years.]
Secondary	progression free survival	the date of first treatment to the first recording of disease progression or death from any cause.	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.