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New combo therapy aims to fight rare nasal cancer before surgery

NCT ID NCT07614828

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether giving immunotherapy (Toripalimab) and chemotherapy (Temozolomide) before surgery can improve outcomes for people with a rare type of melanoma in the nasal cavity. The study will enroll 25 participants with resectable tumors. The main goal is to see if this approach can delay or prevent the cancer from spreading to other parts of the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Toripalimab (immunotherapy) and Temozolomide (chemotherapy)
What this could lead to
If successful, this approach could improve survival and reduce cancer spread in people with a rare and aggressive nasal melanoma.
What could go wrong
This is a small, early-phase trial with only 25 participants, so results may not apply broadly. The combination of treatments may cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Jun 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 coagulation disorders. * Patients with autoimmune diseases. * Patients currently using immunosuppressants, or receiving systemic glucocorticoids for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent), and who continue to use them within 2 weeks prior to first dosing. * Prior treatment with PD-1 monoclonal antibodies or PD-L1 monoclonal antibodies; or a history of severe allergic reactions to other monoclonal antibodies. * Receipt of a live vaccine within 6 weeks prior to first dosing, or the possibility of receiving a live vaccine during the study. * Any condition that may compromise protocol adherence or safety during the study. * Uncontrolled active infection. * Pregnant or breastfeeding women. * Any other condition deemed unsuitable for enrollment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Eye & ENT Hospital

    Shanghai, Shanghai Municipality, 200030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.