Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant M… (NCT07614828) | Clinical Trial Compass
RecruitingPhase 2
Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa
China25 participantsStarted 2023-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, with general condition tolerating chemotherapy and general anesthesia for surgery.
* Locally resectable with curative intent, and able to undergo contrast-enhanced CT or contrast-enhanced MRI examinations.
* Adequate organ function: Hematology: white blood cells ≥3.0 × 10\^9/L; absolute neutrophil count ≥1.5 × 10\^9/L; hemoglobin ≥80 g/L; platelets ≥100 × 10\^9/L. Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN. Coagulation: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Renal function: serum creatinine ≤1.5 × ULN.
* Patients with recurrence after prior curative surgery are allowed; for recurrent patients, chemotherapy and immune therapy must have been discontinued for more than 6 months.
Exclusion Criteria:
* 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 coagul…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distant Metastasis-Free Survival (DMFS)
Timeframe: from sign informed consent to 24 months, assessed every 4-8week during treatment, 12 weeks in year 1 and every 24 weeks thereafter.