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

Primary Purpose

Malignant Melanoma, Sinonasal Melanoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
endoscopic surgery
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Eye& ENT Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endonasal endoscopic surgery with adjuvant therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Overall survival
3 year Overall Survival rate

Secondary Outcome Measures

progression free survival
the date of first treatment to the first recording of disease progression or death from any cause.

Full Information

First Posted
May 5, 2021
Last Updated
May 8, 2022
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04879654
Brief Title
Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma, Sinonasal Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endonasal endoscopic surgery with adjuvant therapy
Arm Type
Experimental
Arm Description
endonasal endoscopic surgery followed by Toripalimab,radiotherapy and/or chemotherapy
Intervention Type
Procedure
Intervention Name(s)
endoscopic surgery
Other Intervention Name(s)
radiotherapy, chemotherapy, Toripalimab
Intervention Description
endoscopic surgery followed by multimodality treatment including radiotherapy,Toripalimab,and/or chemotherapy
Primary Outcome Measure Information:
Title
Overall survival
Description
3 year Overall Survival rate
Time Frame
From date of first treatment until the date of death from any cause,through study completion,up to 3 years.]
Secondary Outcome Measure Information:
Title
progression free survival
Description
the date of first treatment to the first recording of disease progression or death from any cause.
Time Frame
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 Pre-specified Outcome Measures:
Title
Local progression free survival
Description
the date of first treatment to local failure or death
Time Frame
From date of first treatment to local failure or date of death from any cause,through study completion,up to 3 years.
Title
Regional progression free survival
Description
the date of first treatment to regional failure or death
Time Frame
From date of first treatment to regional failure or date of death from any cause, through study completion,up to 3 years.
Title
Distant metastasis free survival
Description
the date of first treatment to distant metastasis or death
Time Frame
From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 3 years.]
Title
Toxicities
Description
Using CTCAE Version5.0 to evaluate
Time Frame
From date of first treatment through study completion,up to 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaole Song, MD
Phone
15821388769
Email
jxfxsxl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongmeng Yu, MD,PHD
Organizational Affiliation
Eye&ENT Hospital,Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye& ENT Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yan, MD
Phone
13761720601
Email
yanl13@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaoshen Wang, PHD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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