Actively Recruiting
Clinical Study of Adbelimumab in the Adjuvant Treatment of Esophageal Squamous Cell Carcinoma.
Led by Hebei Medical University Fourth Hospital · Updated on 2025-12-05
142
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluating the efficacy and safety of adebrelizumab for the adjuvant treatment of esophageal squamous cell cancer.
CONDITIONS
Official Title
Clinical Study of Adbelimumab in the Adjuvant Treatment of Esophageal Squamous Cell Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Histopathologically confirmed esophageal squamous cell cancer with initial clinical stage cT1b-2N1-3M0 or cT3-4aN0-3M0 in the thoracic esophagus
- Radical surgery with R0 resection 4 to 16 weeks before randomisation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Expected survival of at least 12 months
- Left ventricular ejection fraction greater than 50%
- Normal major organ function based on blood tests and biochemical examinations
- Willing to participate with written informed consent and good adherence to follow-up
You will not qualify if you...
- Patients initially diagnosed as unresectable and treated with conversion therapy
- Severe postoperative complications making adjuvant therapy unsuitable
- Patients who have received any adjuvant therapy after surgery
- Patients receiving or having received chemotherapy, radiotherapy, or targeted therapy
- Pre-existing other malignancies unless in complete remission for at least 5 years
- Active, known or suspected autoimmune diseases except controlled cases as defined
- Active hepatitis B or C virus infection
- Pregnant or breastfeeding women, or women with history of immunodeficiency not using contraception
- Clinically uncontrolled cardiac conditions such as NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Not suitable for enrolment based on investigator's comprehensive assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
12, Jiankang road, Chang'an District, Shijiazhuang, Hebei 050000, China
Shijiazhuang, Hebei, China
Actively Recruiting
Research Team
Z
Ziqiang Tian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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