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Can a Two-Drug punch shrink eyelid tumors before surgery?

NCT ID NCT07740993

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing whether giving two drugs—sintilimab and disitamab vedotin—before surgery can shrink tumors in people with a rare type of eyelid cancer called sebaceous gland carcinoma. Participants receive two cycles of the combination, then undergo surgery to remove the tumor, followed by up to a year of maintenance therapy with sintilimab alone. The study aims to see how many patients have a major or complete response in the tumor tissue after this pre-surgery treatment, and to assess safety and how long patients stay cancer-free.

What this could mean

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

Active substance
Sintilimab combined with disitamab vedotin
What this could lead to
If successful, this combination could shrink eyelid tumors before surgery, potentially making surgery easier and reducing the chance of the cancer coming back.
What could go wrong
This is a small, early-phase study, so results may not apply broadly. The drugs can cause immune-related side effects, and the treatment may not work for everyone.

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 25 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 85 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: 1.Age 18 to 85 years (inclusive), regardless of gender; 2.Pathologically confirmed sebaceous gland carcinoma of the eyelid meeting the following criteria: a) Locally advanced disease; b) Deemed resectable or potentially resectable based on ophthalmic evaluation; c) Willing to undergo surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 4. Adequate organ and bone marrow functions defined as follows: a) Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 80 × 10\^9/L; Hemoglobin ≥ 8 g/dL; b) Hepatic function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; c) Serum albumin ≥ 2.8 g/dL; d) Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCR) \> 60 mL/min; e) Coagulation function: International Normalized Ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 5. Volunteer to participate in the study, provide written informed consent, and be capable of complying with all protocol-specified visits and related procedures Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1) History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and gastrointestinal intramucosal carcinoma with no recurrence within 5 years, or other malignancies deemed eligible by the investigator; 2) Any active autoimmune disease or history of autoimmune disease; 3) History of allergic diseases, severe drug allergies, or any component of the prescription (Note: severe allergy refers to those resulting in hospitalization); 4) Received any of the following treatments: a) Prior treatment with anti-PD-1, anti-PD-L1, or anti-HER2 therapies; b) Prior vaccination with anti-tumor vaccines; c) Use of any live vaccines against infectious diseases (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to the first dose or planned during the study period; d) Major surgery or severe trauma within 4 weeks prior to the first dose; 5) Concomitant severe medical conditions; 6) Known history of interstitial lung disease (ILD), non-infectious pneumonitis, or high suspicion of ILD, or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity (subjects with a history of drug-induced or radiation-induced asymptomatic non-infectious pneumonitis are allowed to be enrolled), active tuberculosis, or a history of tuberculosis infection that remains uncontrolled after treatment; 7) Patients with hyperthyroidism and patients with organic thyroid diseases cannot be enrolled, patients with hypothyroidism on a stable dose of thyroid hormone replacement therapy can be enrolled, and patients with hypothyroidism controlled by thyroid hormone replacement therapy can be enrolled (whether it is controlled shall be confirmed by the investigator and/or the endocrinology department); 8) Active infection, or unexplained fever occurring during screening or within 48 hours prior to the first dose, or use of systemic antibiotics within 1 week prior to signing the informed consent form; 9) Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection of the assay), or a known history of positive human immunodeficiency virus (HIV) test, or known acquired immunodeficiency syndrome (AIDS); 10) Clear prior history of neurological or psychiatric disorders, such as epilepsy or dementia; 11) Clear history of drug abuse or history of alcohol abuse within 3 months; 12) Pregnant or lactating women, subjects (and their partners) who have reproductive plans, engage in unprotected sexual intercourse, or are unwilling to adopt appropriate contraceptive methods (such as condoms, intrauterine devices, or partner ligation) from the screening period up to 3 months after the end of the study; 13) Received any investigational drug within 4 weeks prior to the first use of the study drug, or concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up phase of an interventional clinical study; 14) Other factors deemed by the investigator that may affect the study, leading to the inability to complete study treatment and follow-up

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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.

How to take part

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

  1. The places running it

    1 site. 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

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, China