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Can a Three-Drug cocktail shrink esophageal tumors before surgery?

NCT ID NCT07780721

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This phase 2 trial is testing whether giving a combination of adebrelimab (an immunotherapy), thymalfasin (an immune booster), and chemotherapy before surgery can improve outcomes for people with resectable esophageal squamous cell carcinoma. The study will enroll about 31 adults in China who will receive 2-3 cycles of the combination, followed by surgery. The main goal is to see how often the tumor completely disappears after this pre-surgical treatment.

What this could mean

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

Active substance
A combination of adebrelimab (an immunotherapy drug), thymalfasin (an immune-boosting peptide), and chemotherapy (nab-paclitaxel plus either cisplatin or carboplatin), given before surgery.
What this could lead to
If successful, this approach could improve the chances of eliminating the tumor before surgery, potentially leading to better long-term outcomes for people with esophageal cancer.
What could go wrong
This is an early-phase, small study (31 participants) without a comparison group, so results may not be definitive. The combination may increase side effects, and the added benefit of thymalfasin is uncertain.

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 31 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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 80 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: * Has signed the written informed consent form and voluntarily participates in this study; * Aged 18-80 years, male or female; * Histopathologically or cytologically confirmed esophageal squamous cell carcinoma; * Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0; * Has at least one measurable lesion (per RECIST Version 1.1: the measurable lesion has a longest diameter ≥10 mm on spiral CT scan, or a malignant lymph node with short-axis diameter ≥15 mm); * Expected to achieve R0 resection; * ECOG Performance Status (PS) 0-1 (see Appendix 1); * Has not received any prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; * Plans to receive surgical resection after completion of neoadjuvant therapy; * No contraindications to surgery. * Adequate organ function as specified below: 1. Hematology laboratory values (No blood products, hematopoietic growth factors, leukopoietic agents, thrombopoietic agents or anti-anemia medications are permitted within 14 days prior to the first study drug administration): White blood cell count ≥ 3.0 × 10⁹/L Absolute neutrophil count ≥ 1.0 × 10⁹/L Platelet count ≥ 80 × 10⁹/L Hemoglobin ≥ 90 g/L 2. Serum chemistry: 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 reproductive potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of study drug, and must use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for at least 3 months after the last dose of study drug. Male subjects with female partners of reproductive potential must use effective contraception throughout the study and for 3 months after the last dose. * Subjects with good compliance and willingness to complete follow-up visits. Exclusion Criteria: * Tumor invades adjacent organs of the esophageal lesion (major arteries or trachea); * Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; * Poor nutritional status with BMI \< 18.5 kg/m². Subjects whose nutritional status is corrected by symptomatic nutritional support prior to enrollment may be considered for inclusion upon assessment by the principal investigator; * History of allergy to any component of monoclonal antibodies, adebrelimab, thymalfasin, paclitaxel, carboplatin or other platinum agents; * Previously received or currently receiving any of the following treatments: 1. Any anti-tumor radiotherapy, chemotherapy, immunotherapy, targeted therapy or other anti-neoplastic agents; 2. Immunosuppressive agents or systemic corticosteroids administered for immunosuppressive purposes (prednisone \>10 mg/day or equivalent dose) within 2 weeks prior to the first study drug administration. Inhaled or topical steroids, and corticosteroid replacement therapy (prednisone \>10 mg/day or equivalent dose) are permitted in the absence of active autoimmune disease; 3. Live attenuated vaccines administered within 4 weeks prior to the first study drug administration; 4. Major surgery or severe trauma within 4 weeks prior to the first study drug administration. * Active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects receiving hormone replacement therapy may be enrolled). Subjects with psoriasis or childhood asthma/allergies completely resolved without any intervention in adulthood can be considered eligible; patients requiring medical intervention with bronchodilators are excluded. * History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, history of solid organ transplantation or allogeneic bone marrow transplantation; * Poorly controlled cardiac signs or diseases, including but not limited to: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still poorly controlled after intervention. * Severe infection (CTCAE Grade \>2) within 4 weeks before the first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Active pulmonary inflammation indicated by baseline chest imaging; subjects presenting with signs and symptoms of infection within 14 days before first dosing or requiring oral/intravenous antibiotics, except for prophylactic antibiotic use. * Active pulmonary tuberculosis confirmed by medical history or CT scan; history of active pulmonary tuberculosis within 1 year before enrollment; or history of active pulmonary tuberculosis more than 1 year previously without standardized treatment. * Hereditary bleeding diathesis or coagulation disorders. Clinically significant bleeding events or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++. * Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, except malignancies with low risk of metastasis or death (5-year survival rate \>90%). Fully treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of cervix, etc., may be considered for enrollment. * Pregnant or breastfeeding women. * Any other conditions judged by the investigator that may force premature study discontinuation, such as other severe diseases (including psychiatric disorders) requiring combined medication, alcohol abuse, drug abuse, family or social factors that may affect subject safety or 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

  • Affiliated Hospital of Putian University

    Putian, Fujian, 351100, China

More trials for these conditions

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