Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery
Sponsor
Eye & ENT Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04879654
Collaborator
Chinese Academy of Medical Sciences (Other)
45
1
1
60
0.8
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
May 1, 2021
Anticipated Primary Completion Date
:
May 1, 2026
Anticipated Study Completion Date
:
May 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: endonasal endoscopic surgery with adjuvant therapy endonasal endoscopic surgery followed by Toripalimab,radiotherapy and/or chemotherapy |
Procedure: endoscopic surgery
endoscopic surgery followed by multimodality treatment including radiotherapy,Toripalimab,and/or chemotherapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival [From date of first treatment until the date of death from any cause,through study completion,up to 3 years.]]
3 year Overall Survival rate
Secondary Outcome Measures
- 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.]
the date of first treatment to the first recording of disease progression or death from any cause.
Other Outcome Measures
- 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.]
the date of first treatment to local failure or death
- 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.]
the date of first treatment to regional failure or death
- 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.]]
the date of first treatment to distant metastasis or death
- Toxicities [From date of first treatment through study completion,up to 3 years.]
Using CTCAE Version5.0 to evaluate
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
- 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;
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye& ENT Hospital, Fudan University | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
- Chinese Academy of Medical Sciences
Investigators
- Principal Investigator: Hongmeng Yu, MD,PHD, Eye&ENT Hospital,Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hongmeng Yu,
MD,PhD,
Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT04879654
Other Study ID Numbers:
- SNMM-SA-V1
First Posted:
May 10, 2021
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: