Actively Recruiting
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)
Led by Akeso · Updated on 2025-12-31
90
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, multi-center phase II/III study. All patients are resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of perioperative Cadonilimab combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in patients with resectable ESCC.
CONDITIONS
Official Title
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and follow study procedures
- Aged 18 to 75 years old
- Pathologically confirmed resectable esophageal squamous cell carcinoma
- Adequate lung function
- Adequate tumor tissue samples available
- ECOG performance status of 0 or 1
- Adequate organ function
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception during treatment and for 120 days after last dose
You will not qualify if you...
- Suspected distant metastases or unresectable locally advanced disease
- Other pathological types confirmed by histology
- Previous surgery that prevents gastric substitution for esophageal reconstruction
- History of other cancers within past 5 years
- Severe esophagogastric varices, active ulcers, unhealed wounds, gastrointestinal perforation, or intestinal obstruction within 4 weeks before randomization
- Active or past inflammatory bowel disease
- Symptomatic or recurrent pleural, pericardial, or ascitic fluid needing drainage
- Uncontrolled illnesses
- Acute worsening of chronic obstructive pulmonary disease within 4 weeks prior to randomization
- History of myocardial infarction, unstable angina, or heart failure within 12 months before treatment
- History of severe bleeding or coagulation problems
- Arterial thromboembolic events within 6 months before randomization
- History or current non-infectious pneumonitis or interstitial lung disease requiring systemic steroids
- Known psychiatric disorders, drug abuse, or substance addiction
- Pregnant or breastfeeding women
- Previous systemic or local cancer therapy for this esophageal cancer
- Systemic immunomodulatory therapy within 2 weeks before randomization
- Major surgery or severe trauma within 4 weeks before randomization
- Allergy to any study drug component
- Active autoimmune disease needing systemic treatment within 2 years before randomization
- Active hepatitis B infection
- Active tuberculosis
- Severe infection within 4 weeks before randomization
- History of immunodeficiency or positive HIV test
- Active syphilis infection
- Live vaccination within 4 weeks before randomization or planned during study
- History of organ or stem cell transplantation
- Currently participating in another investigational drug or device study
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Air Force Medical University
Xi'an, China
Actively Recruiting
Research Team
W
Wenting Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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