Could a drug combo let some esophageal cancer patients skip surgery?
NCT ID NCT07584031
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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