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Promising drug cocktail aims to shrink aggressive nasal tumors before surgery

NCT ID NCT07616141

Disease control Sponsor: Eye & ENT Hospital of Fudan University Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether giving a combination of anlotinib (a targeted therapy) and epirubicin (chemotherapy) before surgery can improve outcomes for people with advanced sinonasal adenoid cystic carcinoma, a rare and aggressive cancer of the nasal cavity and sinuses. About 76 participants will receive two cycles of the drugs, then undergo surgery and radiation. The main goal is to see if this approach increases the 3-year survival without cancer progression compared to historical rates.

What this could mean

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

Active substance
anlotinib (a targeted therapy) plus epirubicin (a chemotherapy drug)
What this could lead to
If successful, this drug combination before surgery could become a new standard treatment for advanced sinonasal adenoid cystic carcinoma, potentially improving survival and reducing the need for disfiguring surgeries.
What could go wrong
This is an early phase II trial with only 76 participants and no comparison group. The combination may cause side effects like fatigue, bleeding, or heart problems, and may not improve outcomes over current treatments.

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.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

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 to 75 years

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: * Age 18 to 75 years, any sex. * Histopathologically confirmed sinonasal adenoid cystic carcinoma (any subtype). * Stage T4a or T4b according to AJCC 8th edition. If lymph node metastasis is present, it must be surgically resectable. If distant metastasis is present, metastatic lesions must be stable. * Multidisciplinary team (MDT) assessment confirms that the tumor is technically resectable but with high risk (invasion of skull base, orbit, dura, etc.). * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Adequate bone marrow, liver, kidney, and cardiac function: absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; ALT/AST ≤2.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN; creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; left ventricular ejection fraction (LVEF) ≥50%. * Willing to participate and able to provide written informed consent (including for clinical treatment and translational research). Exclusion Criteria: * Prior radiotherapy to the head and neck region. * Prior anthracycline therapy with cumulative dose ≥300 mg/m². * Known hypersensitivity to any component of anlotinib or epirubicin. * Uncontrolled hypertension, severe cardiovascular disease, or active infection. * Pregnant or breastfeeding women. * Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study compliance or conduct.

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Conditions

The condition(s) this trial relates to.

adenoid cystic carcinoma paranasal sinus adenoid cystic carcinoma

As listed by the trial registrant

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

Adenoid cystic carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200030, China

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