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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

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

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study (NCT07437898) is a Phase 2 interventional studying Esophageal Squamous Cell Carcinoma, sponsored by The Affiliated Hospital of Putian University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Squamous Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 42 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Provided written willing to sign a consent form and voluntarily enrolled in this study; - Aged 18-75 years, male or female; - diagnosed by tissue sample (biopsy-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; - your organs (liver, kidneys, etc.) are working well enough based on blood tests, 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 blood count (hemoglobin) at least 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 kidney function (creatinine clearance) at least 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Adebrelimab

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

DRUG

chemotherapy

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).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Affiliated Hospital of Putian University
Putian, Fujian, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07437898), the sponsor (The Affiliated Hospital of Putian University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07437898 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07437898?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07437898?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07437898. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07437898. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.