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

NCT04879654 | Recruiting Phase 2

• 1 other identifier: SNMM-SA-V1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (4)

• Local progression free survival

  From date of first treatment to local failure or date of death from any cause,through study completion,up to 3 years.

• Regional progression free survival

  From date of first treatment to regional failure or date of death from any cause, through study completion,up to 3 years.

• Distant metastasis free survival

  From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 3 years.]

Study Arms (1)

endonasal endoscopic surgery with adjuvant therapy

EXPERIMENTAL

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

Procedure: endoscopic surgery

Interventions

endoscopic surgery PROCEDURE

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

Also known as: radiotherapy, chemotherapy, Toripalimab

endonasal endoscopic surgery with adjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Endoscopy; Radiotherapy; Drug Therapy; toripalimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Therapeutics

Study Officials

• Hongmeng Yu, MD,PHD

  Eye&ENT Hospital,Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaole Song, MD

CONTACT

15821388769; jxfxsxl@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)