Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEye & ENT Hospital of Fudan University

About this trial

Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. This prospective clinical study aims to explore the survival prognosis of neoadjuvant immunotherapy combing radiochemotherapy after Endoscopic Surgery for resectable SNMM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathologically confirmed diagnosis of malignant melanoma of the nasal cavity and paranasal sinuses.

T stage of T3 or T4a.

Age ≥18 years.

No distant metastasis.

Disqualifiers

Patients who refuse to sign the informed consent form.

Patients with uncontrolled comorbidities that, in the investigator's judgment, would interfere with treatment.

Patients currently suffering from another malignant tumor or with synchronous multiple primary tumors that require treatment.

Patients with surgical contraindications, such as severe cardiopulmonary disease or coagulation disorders.

Trial design

Design model

Single group

Treatments tested in this trial

  • neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery

    Drug

    neoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic SurgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Distant Metastasis-Free Survival (DMFS)

the time from sign informed consent to the first documentation of distant metastatic recurrence or death from any cause, whichever occurs first.

Time frame
from sign informed consent to 24 months, assessed every 4-8week during treatment, 12 weeks in year 1 and every 24 weeks thereafter.

Secondary outcomes

Other outcomes

Sponsors and contacts

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