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New drug cocktail aims to wipe out esophageal tumors before surgery

NCT ID NCT07388095

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase II trial tests a combination of three drugs (adebrelimab, nimotuzumab, and chemotherapy) given before surgery to 22 patients with resectable esophageal squamous cell carcinoma. The main goal is to see if the cancer disappears completely after treatment. If it works, this approach could improve outcomes for patients with this type of cancer.

What this could mean

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

Active substance
Adebrelimab, nimotuzumab, cisplatin, and albumin-bound paclitaxel
What this could lead to
If successful, this combination could become a new standard neoadjuvant therapy to improve complete tumor removal and survival in esophageal cancer.
What could go wrong
This is a small, early-phase exploratory trial with only 22 patients, so results may not be generalizable. The drug combination may cause significant side effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 22 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 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: 1. Signed written informed consent to voluntarily participate in this study; 2. Pathologically confirmed resectable esophageal squamous cell carcinoma (excluding mixed adenocarcinoma-squamous cell carcinoma types); 3. Thoracic esophageal cancer confirmed by CT/MRI/EUS assessment with clinical stage IIA-IIIB (according to AJCC 8th edition); 4. Age 18-75 years, male or female; 5. ECOG PS 0-1; 6. No prior anticancer treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery; 7. Planned surgical treatment following completion of neoadjuvant therapy; 8. No surgical contraindications; 9. Normal major organ function, including: (1) Complete blood count (no use of blood components, cell growth factors, leukocyte-stimulating agents, platelet-stimulating agents, or anemia-correcting agents within 14 days prior to first study drug administration): White blood cell count ≥ 4.0 × 10\^9/L Neutrophil count ≥ 1.5 × 10\^9/L Platelet count ≥ 90 × 10\^9/L Hemoglobin ≥ 90 g/L (2) Blood Biochemistry Tests: Total Bilirubin ≤ 1.5×ULN, LT ≤ 2.5×ULN, AST ≤ 2.5×ULN, Serum Creatinine ≤ 1.5×ULN, or Creatinine Clearance ≥ 50 mL/min (Cockcroft-Gault formula) c) Coagulation Function: International Normalized Ratio (INR) ≤ 1.5×ULN Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN 10. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of study drug administration and must use effective contraception (e.g., intrauterine device, oral contraceptives, or 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; 11. Subjects must demonstrate good compliance and willingness to participate in follow-up. Exclusion Criteria: 1. Tumor has significantly invaded adjacent organs (major arteries or trachea) near the esophageal lesion; 2. Presence of supraclavicular lymph node metastasis; 3. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 4. Malnutrition with BMI \< 18.5 kg/m²; if corrected by symptomatic nutritional support prior to enrollment and approved by the principal investigator, enrollment may still be considered; 5. History of allergy to monoclonal antibodies, any component of adebrelimab, any component of Nimotuzumab, albumin-bound paclitaxel, cisplatin, or other platinum-based drugs; 6. Prior or current treatment with any of the following: (1) Any radiation therapy, chemotherapy, or other anti-neoplastic agents directed at the tumor; (2) Use of immunosuppressive agents or systemic corticosteroids for immunosuppression (dose \>10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration; Inhaled or topical steroids and corticosteroid replacement therapy at a dose \>10 mg/day of prednisone or equivalent are permitted in the absence of active autoimmune disease; (3) Received a live attenuated vaccine within 4 weeks prior to the first dose of study drug; (4) Undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of study drug; 7. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Individuals with psoriasis or childhood asthma/allergies that have achieved complete remission and require no intervention in adulthood may be considered for inclusion; however, patients requiring medical intervention with bronchodilators are excluded; 8. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation; 9. Uncontrolled cardiac clinical symptoms or disease, including but not limited to: (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias uncontrolled despite clinical intervention or with poor control after intervention; 10. Severe infection (CTCAE ≥ Grade 2) within 4 weeks prior to first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, or infection-related complications; exclusion if baseline chest imaging indicates active pulmonary inflammation, or if symptoms/signs of infection or need for oral/IV antibiotics exist within 14 days prior to first study drug administration (excluding prophylactic antibiotic use); 11. Active pulmonary tuberculosis infection identified through medical history or CT examination; history of active pulmonary tuberculosis infection within 1 year prior to enrollment; or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment; 12. Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10\^4 copies/mL) or hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the assay method); 13. Imaging demonstrating tumor invasion into the perivascular space of a major vessel, or patients judged by the investigator to be at high risk of fatal hemorrhage due to tumor invasion into a major vessel during the study period; 14. Patients diagnosed with other malignancies within 5 years prior to first administration of the study drug, unless the malignancy carries a low risk of metastasis or mortality (5-year survival rate \> 90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ, which may be considered for inclusion; 15. Patients with uncontrolled hypertension despite antihypertensive therapy (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); or patients requiring two or more antihypertensive agents to control blood pressure; patients with a history of hypertensive crisis or hypertensive encephalopathy; 16. Pregnant or lactating women; 17. Other factors deemed by the investigator to potentially necessitate premature study discontinuation, such as concomitant treatment for other serious illnesses (including psychiatric disorders), alcohol abuse, substance misuse, or familial/social factors that may compromise subject safety or compliance. 18. Other circumstances deemed unsuitable for inclusion by the investigator.

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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

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  1. 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 ↗

  2. A doctor treating you

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