Can a drug combo shrink esophageal tumors before surgery?

NCT ID NCT07823270

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether giving sacituzumab tirumotecan plus toripalimab before surgery helps people with locally advanced esophageal squamous cell carcinoma. Participants receive three cycles of the combination, then undergo standard surgery to remove the tumor. The main goal is to see how often no cancer cells remain in the removed tissue, which doctors call a pathologic complete response.

What this could mean

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

Active substance
sacituzumab tirumotecan combined with toripalimab
What this could lead to
If it works, this combination could become a new pre-surgery option that helps more people with locally advanced esophageal cancer achieve a deep response before their operation.
What could go wrong
This is a small, single-arm phase II study, so any benefit seen may not hold up in larger randomized trials. The drugs can cause infusion reactions and immune-related side effects, and some participants may not respond.

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 33 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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: * Age \>=18 years at the time of informed consent, either sex. * Histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma. * Judged by imaging and esophagoscopy as resectable and requiring neoadjuvant therapy, with clinical stage cT1-2N+M0 or T3-4N0-3M0 (stage II-IVA). * No prior antitumor therapy for esophageal squamous cell carcinoma. * At least one measurable lesion per RECIST v1.1. * ECOG performance status of 0 or 1 within 7 days before dosing. * Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor within 2 weeks before the first dose): * Hematology: NEUT# \>=1.5x10\^9/L; PLT \>=100x10\^9/L; hemoglobin \>=90 g/L. * Hepatic: AST and ALT \<=2.5xULN (\<=5xULN for participants with baseline liver metastases); albumin \>=30 g/L; total bilirubin \<=1.5xULN. * Renal: creatinine clearance \>=60 mL/min (Cockcroft-Gault formula). * Coagulation: INR, APTT, and PT \<=1.5xULN. * Normal thyroid function, defined as TSH within the normal range. If baseline TSH is outside the normal range, participants with total T3 (or FT3) and FT4 within the normal range are also eligible. * Cardiac enzymes within the normal range (isolated laboratory abnormalities judged by the investigator as not clinically significant are allowed). * Left ventricular ejection fraction \>=55%. * Women of childbearing potential and men with partners of childbearing potential must agree to use effective medical contraception from informed consent until 6 months after the last dose. * Participants voluntarily join the study, sign the informed consent form, and are able to comply with the scheduled visits and procedures. Exclusion Criteria: * Any prior antitumor therapy for the currently diagnosed esophageal squamous cell carcinoma. * History of other malignancies within 5 years (except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix). * Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose or during the study. * Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that interferes with or delays corneal healing. * Any of the following cardiovascular or cerebrovascular diseases or risk factors: * Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, grade 3 or 4 heart failure (NYHA classification), symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular or cerebrovascular diseases within 6 months before dosing. * History of myocarditis, primary cardiomyopathy, or specific cardiomyopathy. * Any deep vein thrombosis (participants stabilized with low molecular weight heparin or similar therapy for \>=2 weeks may be allowed), peripheral arterial thromboembolic event, pulmonary embolism, or other severe thromboembolic events within 3 months before dosing. * Aortic aneurysm, aortic dissecting aneurysm, or other major vascular disease that may be life-threatening or requires surgery within 6 months before dosing. * Uncontrolled systemic disease as judged by the investigator: * Poorly controlled diabetes mellitus (two consecutive fasting glucose levels \>=9 mmol/L). * Poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg). * Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage. * History of steroid-requiring (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening. * Active autoimmune disease requiring systemic treatment within the past 2 years, including disease-modifying drugs, immunosuppressants, or systemic corticosteroids (\>10 mg/day prednisone or equivalent). Hormone replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency is not considered systemic treatment. Participants receiving systemic corticosteroids \>10 mg/day prednisone or other immunosuppressive drugs within 2 weeks before dosing. * Known active pulmonary tuberculosis. Participants with suspected active pulmonary tuberculosis must undergo clinical evaluation to exclude it. * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Active hepatitis B (HBsAg positive with HBV-DNA \>=500 IU/mL or above the lower limit of detection, whichever is higher) or hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection). Participants who are HBsAg positive are required to receive anti-hepatitis B viral therapy during the study. * Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. * Known hypersensitivity to the study drugs or any of their components, or a history of severe hypersensitivity reactions to other biologics. * Severe infection within 4 weeks before dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks before dosing. * Receipt of non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or Chinese patent medicines approved for antitumor indications within 2 weeks before dosing. * Receipt of a live vaccine within 30 days before dosing, or planned receipt of a live vaccine during the study. * Rapid deterioration during screening before dosing, such as a marked change in performance status. * Pregnant or breastfeeding women. * Local or systemic diseases caused by non-malignant conditions, or diseases or symptoms secondary to the tumor, that may lead to high medical risk and/or uncertainty in survival evaluation, such as leukemoid reaction or cachexia. * Any condition that, in the investigator's judgment, interferes with the evaluation of the study drug, participant safety, or interpretation of study results, or any other condition that makes the participant unsuitable for this study.

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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

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, Hebei, 050011, China

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