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Immunotherapy plus chemo shows promise for esophageal cancer before surgery

NCT ID NCT07437898

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether giving the immunotherapy drug adebrelimab along with standard chemotherapy before surgery can help people with locally advanced esophageal cancer. About 42 participants will receive the treatment every 3 weeks, then have surgery. The main goal is to see how many patients have no cancer cells left in the removed tissue (pathological 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
adebrelimab (an immunotherapy drug) plus chemotherapy (nab-paclitaxel and cisplatin)
What this could lead to
If successful, this combination could become a standard pre-surgery treatment to shrink tumors and improve survival for esophageal cancer patients.
What could go wrong
This is a small, early-phase trial with only 42 participants, so results may not apply broadly. Side effects from immunotherapy and chemotherapy can be serious.

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 42 people

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

Started

Sep 2024

Expected to finish

Dec 2026

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: * Provided written informed consent and voluntarily enrolled in this study; * Aged 18-75 years, male or female; * Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC); * Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0; * At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria: long axis ≥10 mm on spiral CT for target lesions, or short axis ≥15 mm for malignant lymph nodes; * Predicted to be eligible for R0 resection; * Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 (see Appendix 1); * No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; * Planned to undergo surgical resection after completion of neoadjuvant therapy; * No contraindications to surgery; * Adequate organ function, as defined below: 1. Hematologic parameters (no blood products, colony-stimulating factors, leukocyte-raising agents, platelet-raising agents, or anti-anemia agents permitted within 14 days prior to the first dose of study drug): White blood cell (WBC) count ≥ 3.0×10⁹/L Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L Platelet count ≥ 80×10⁹/L Hemoglobin ≥ 90 g/L 2. Blood biochemistry: Total bilirubin ≤ 1.5×ULN Alanine transaminase (ALT) ≤ 2.5×ULN; aspartate transaminase (AST) ≤ 2.5×ULN Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula, see Appendix 2) 3. Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN * Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours before initiation of study drug administration, and use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) during the trial and for at least 3 months after the last dose.Male subjects with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose; * Good subject compliance and willingness to comply with study follow-up requirements. Exclusion Criteria: * Significant tumor invasion into adjacent organs of the esophageal lesion (e.g., major arteries or trachea); * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; * Poor nutritional status with a Body Mass Index \<18.5 kg/m² (BMI \<18.5 kg/m²); subjects whose BMI is corrected with targeted nutritional support prior to randomization may be considered for enrollment at the discretion of the principal investigator; * History of hypersensitivity to monoclonal antibodies, any component of adebrelimab, paclitaxel, cisplatin, or other platinum-based agents; * Previous or ongoing receipt of any of the following therapies: 1. Any radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapy for malignancy; 2. Systemic immunosuppressive therapy or systemic corticosteroid therapy for immunosuppressive purposes (prednisone \>10 mg/day or equivalent dose) within 2 weeks prior to the first dose of study drug; Inhaled or topical steroids, and corticosteroid replacement therapy at prednisone \>10 mg/day or equivalent dose are permitted in the absence of active autoimmune disease; 3. Live attenuated vaccine within 4 weeks prior to the first dose of study drug; 4. Major surgery or severe traumatic injury within 4 weeks prior to the first dose of study drug; * Any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects with hypothyroidism controlled by hormone replacement therapy may be considered for enrollment. Subjects with fully resolved psoriasis or childhood asthma/allergies requiring no adult intervention may be considered, while those requiring medical intervention with bronchodilators are excluded; * History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, history of organ transplantation, or allogeneic bone marrow transplantation; * Poorly controlled cardiac symptoms or diseases, including but not limited to: 1. Heart failure of New York Heart Association Class II (NYHA Class II) or higher; 2. Unstable angina pectoris; 3. Myocardial infarction within 1 year; 4. Clinically significant supraventricular or ventricular arrhythmias that are either untreated or poorly controlled despite clinical intervention; * Severe infection (Common Terminology Criteria for Adverse Events Grade \>2 (CTCAE Grade \>2)) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Subjects with active pulmonary inflammation on baseline chest imaging, signs/symptoms of infection, or requiring oral or intravenous antibiotic therapy within 14 days prior to the first dose of study drug are excluded, except for prophylactic antibiotic use; * Active tuberculosis confirmed by medical history or CT scan, history of active tuberculosis within 1 year prior to enrollment, or history of active tuberculosis more than 1 year prior to enrollment without standard anti-tuberculosis treatment; * Hereditary bleeding diathesis or coagulopathy. Clinically significant bleeding or documented bleeding tendency within 3 months prior to enrollment, including gastrointestinal bleeding, hemorrhagic gastric ulcer, and stool occult blood ≥++ at baseline; * Diagnosis of another malignancy within 5 years prior to the first dose of study drug, except for malignancies with low metastatic or mortality risk (5-year survival rate \>90%), such as adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, which may be considered for enrollment; * Female subjects who are pregnant or breastfeeding; * Any other conditions judged by the investigator that may result in premature study discontinuation, including concurrent treatment for other severe diseases (including psychiatric disorders), alcoholism, substance abuse, or family/social factors that may compromise subject safety or study compliance.

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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

  • The Affiliated Hospital of Putian University

    RECRUITING

    Putian, Fujian, 351100, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.