A Phase 2 interventional study of endoscopic surgery in Malignant Melanoma and Sinonasal Melanoma, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Eye & ENT Hospital of Fudan University · Phase 2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 45 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
Also known as: radiotherapy, chemotherapy, Toripalimab
Overall survival
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.]
progression free survival
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.
Local progression free survival
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.
Regional progression free survival
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.
Distant metastasis free survival
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.]
Toxicities
Using CTCAE Version5.0 to evaluate
Time frame: From date of first treatment through study completion,up to 3 years.
Plan to share: Yes
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Eye & ENT Hospital of Fudan University