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Could a drug combo let some esophageal cancer patients skip surgery?

NCT ID NCT07584031

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a drug called adebrelimab combined with chemotherapy before deciding on surgery for people with a certain type of esophageal cancer. About 200 participants will receive the treatment first. If the cancer disappears completely on scans, they will be randomly assigned to either watchful waiting with more chemo-immunotherapy or standard surgery. The main goal is to see if watchful waiting can provide similar 2-year cancer-free survival as surgery.

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 200 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

Dec 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 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: * Patients voluntarily participate in this study, sign an informed consent form, and demonstrate good compliance; * At least 18 years of age; gender is not restricted; * ECOG performance status: 0-1; * Patients with histologically confirmed resectable esophageal squamous cell carcinoma clinically staged as (T1N+M0 or T2-4aNanyM0); * No prior anticancer therapy for esophageal cancer, including chemotherapy, hormone therapy, radiation therapy, or immunotherapy; * Laboratory tests must meet the following criteria (within 7 days prior to baseline enrollment): 1. Complete blood count (CBC): 1. Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion within the past 14 days); 2. Neutrophil count (NEUT) ≥ 1.5 × 10⁹/L; 3. Platelet count (PLT) ≥ 100 × 10⁹/L; 4. White blood cell count (WBC) ≥ 3 × 10⁹/L; 2. Biochemical Tests: 1. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN; 2. Serum total bilirubin (TBIL) ≤ 1.5×ULN; 3. Serum creatinine (Cr) ≤ 1.5×ULN; (or creatinine clearance (CCr) ≥ 60 mL/min); 3. Coagulation function: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), and prothrombin time (PT) ≤ 1.5×ULN; 4. Thyroid function: Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, FT3 and FT4 levels should also be evaluated; if FT3 and FT4 levels are normal, the patient may be enrolled); 5. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%; * Female participants must agree to use contraceptive measures, such as an intrauterine device (IUD), oral contraceptives, or condoms, during the study and for 6 months after study completion; they must have a negative serum pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; male participants must agree to use contraceptive measures during the study and for 6 months after study completion. Exclusion Criteria: * Concurrent malignant neoplasms (except for cured basal cell carcinoma of the skin); * Diagnosis of cervical esophageal cancer; * History of severe hypersensitivity reactions following administration of other monoclonal antibodies; * Presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, or nephritis; asthma requiring bronchodilators for medical intervention); however, the following patients are eligible for enrollment: vitiligo, psoriasis, or alopecia not requiring systemic treatment; well-controlled type 1 diabetes; hypothyroidism with normal thyroid function following replacement therapy; * Requiring immunosuppressants, or systemic or absorbable topical corticosteroids for immunosuppressive purposes (dose \> 10 mg/day of prednisone or other corticosteroids of equivalent potency), and still using them within 2 weeks of the first dose; * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; * Uncontrolled symptoms of brain metastases, spinal cord compression, or carcinomatous meningitis occurring within 4 weeks prior to the first dose, or patients with brain or meningeal disease identified by CT or MRI at screening; * Patients with any severe and/or uncontrolled medical conditions, including: 1. Acute or recurrent myocardial ischemia or myocardial infarction; poorly controlled and clinically significant arrhythmias; and heart failure of Class II or higher (New York Heart Association \[NYHA\] functional class); LVEF (left ventricular ejection fraction) \< 50%; 2. Active or uncontrolled severe infection (≥ Grade 2 CTC AE infection); * Receipt of a prophylactic or attenuated vaccine within 4 weeks prior to the first dose; * Other factors, as determined by the investigator, that may lead to forced discontinuation of the study, such as other serious illnesses (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that could compromise the subject's safety. * If HBsAg (+) and/or HBcAb (+), HBV DNA must be \< 500 IU/mL (if the local center's lower limit of detection is higher than 500 IU/mL, the investigator may decide on enrollment based on specific circumstances) and the subject must continue to receive effective anti-HBV therapy during the study, or must have already started treatment with entecavir or tenofovir prior to study drug administration; * If HCV antibodies are positive, HCV-RNA testing must be performed; subjects with HCV-RNA \> 10³ copies/mL must be excluded; * HIV-positive.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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