Actively Recruiting
Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study
Led by The Affiliated Hospital of Putian University · Updated on 2026-02-27
42
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 RECIST 1.1 criteria
- Predicted to be eligible for R0 resection
- Eastern Cooperative Oncology Group performance status 0-1
- No prior anti-tumor therapy for esophageal cancer
- Planned to undergo surgical resection after neoadjuvant therapy
- No contraindications to surgery
- Adequate organ function as defined by hematologic, biochemical, and coagulation parameters
- Female subjects of childbearing potential must have a negative pregnancy test and use effective contraception
- Male subjects with female partners of childbearing potential must use effective contraception
- Good compliance and willingness to follow study requirements
You will not qualify if you...
- Significant tumor invasion into adjacent organs such as major arteries or trachea
- Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage
- Poor nutritional status with BMI less than 18.5 kg/m²
- History of hypersensitivity to study drugs or related components
- Prior or ongoing antitumor therapy or systemic immunosuppressive therapy within specified timeframes
- Live attenuated vaccine within 4 weeks prior to first dose
- Major surgery or severe trauma within 4 weeks prior to first dose
- Active or history of autoimmune diseases except controlled hypothyroidism
- History of immunodeficiency or organ/bone marrow transplantation
- Poorly controlled cardiac diseases including heart failure NYHA II or higher, unstable angina, recent myocardial infarction, or significant arrhythmias
- Severe infection within 4 weeks prior to first dose
- Active tuberculosis or history without proper treatment
- Hereditary bleeding disorders or recent significant bleeding
- Diagnosis of another malignancy within 5 years except certain low-risk cancers
- Female subjects who are pregnant or breastfeeding
- Any other conditions that may risk safety or study compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Putian University
Putian, Fujian, China, 351100
Actively Recruiting
Research Team
J
JinBiao Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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