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Esophageal Squamous Cell CarcinomaPhase 2NCT07437898

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

A Phase 2 study testing Adebrelimab and chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by The Affiliated Hospital of Putian University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a domestic exploratory, single-arm clinical study enrolling patients with histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), aiming to evaluate the efficacy and safety of neoadjuvant adebrelimab plus chemotherapy for locally advanced esophageal squamous cell… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Adebrelimab and chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
3 Sep 2024to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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:
  • 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
  • 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)
  • 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.

Who cannot join

  • 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:
  • Any radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapy for malignancy;
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  • 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;
  • Live attenuated vaccine within 4 weeks prior to the first dose of study drug;
  • 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:
  • Heart failure of New York Heart Association Class II (NYHA Class II) or higher;
  • Unstable angina pectoris;
  • Myocardial infarction within 1 year;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JinBiao Xie contact

13808598778

jinbiaoxie123@163.com

China1 site, 1 recruiting

  • The Affiliated Hospital of Putian University

    Putian, Fujian, 351100

    Recruiting

Other trials in China

About this study

Official title: An Exploratory, Single-Arm, Multicenter Clinical Study of Neoadjuvant Adebrelimab Plus Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

This is a domestic exploratory, single-arm clinical study enrolling patients with histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), aiming to evaluate the efficacy and safety of neoadjuvant adebrelimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC).

Being tested
Adebrelimab, chemotherapy
Keywords
Adebrelimab, chemotherapy, Neoadjuvant
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdebrelimabDrug

    Adebrelimab 1200 mg or 20 mg/kg, intravenous infusion, every 3 weeks (Q3W);

  • chemotherapyDrug

    nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) 100 mg/m² on Days 1 and 8 (D1/D8), intravenous infusion, every 3 weeks (Q3W); Cisplatin 75 mg/m² on Days 1, 2 and 3 (D1/D2/D3), intravenous infusion, every 3 weeks (Q3W).

Study groups in NCT07437898
Study groupRoleWhat they receive
Adebrelimab in combination chemotherapyExperimentalNot described
Receives: Drug: Adebrelimab; Drug: chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response Rate (pCR)

    Measured: Four weeks after surgery

Secondary outcomes (6)

  1. Surgical R0 resection rate

    Measured: Four weeks after surgery

  2. Main pathological relief (MPR)

    Measured: Four weeks after surgery

  3. Disease-Free Survival (DFS)

    Measured: 24-months

  4. Objective Response Rate (ORR)

    Measured: Up to 3 months per two cycles (21 days per cycle)]

  5. Overall Survival (OS)

    Measured: 24-months

  6. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: As long as two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start3 Sep 2024
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07437898
Sponsor's protocol ID
2024123
Status last verified
Feb 2026
First submitted
4 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab and chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by The Affiliated Hospital of Putian University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JinBiao Xie (13808598778, jinbiaoxie123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response Rate (pCR) (time frame: Four weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07437898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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