Actively Recruiting
Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Li Zhang · Updated on 2025-06-26
43
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma. type of study: clinical trial
CONDITIONS
Official Title
Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Male or female aged 18 years or older
- Histologically confirmed esophageal squamous cell carcinoma diagnosed as cT4a, T4b, NXM0 according to the 8th edition of AJCC TNM staging
- Initially assessed as unresectable by the surgeon
- No previous systemic treatment for the current disease, including surgery, radiotherapy, chemotherapy, or immunotherapy
- Agreement to undergo radical surgery and no contraindications for surgery as judged by the surgeon
- ECOG performance status of 0 or 1
- Expected survival time longer than 6 months
- Adequate organ function meeting specified laboratory criteria including neutrophil count, platelets, hemoglobin, liver enzymes, creatinine, coagulation, thyroid function, and myocardial enzymes
- Female participants of childbearing potential must have a negative pregnancy test within 3 days before first treatment
- Use of effective contraception during treatment and for 120 days after the last dose of study drug or 180 days after last chemotherapy dose
You will not qualify if you...
- Diagnosis of other malignant diseases within 5 years prior to first dose, except certain skin cancers and carcinoma in situ that were radically resected
- Active bleeding in the lesion detected by endoscopy
- Participation in other interventional clinical trials or use of investigational drugs or devices within 4 weeks before first dose
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor modulating drugs
- Use of systemic anti-tumor Chinese patent medicines or immunomodulatory drugs within 2 weeks before first dose
- Active autoimmune disease requiring systemic treatment within 2 years before first dose
- Systemic glucocorticoid or immunosuppressive therapy within 7 days before first dose, except physiological doses
- Known history of allogeneic organ or stem cell transplantation (except corneal)
- Allergy to study drugs
- Conditions affecting capecitabine use such as swallowing or intestinal obstruction issues
- Incomplete recovery from toxicity or complications of prior treatments
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccine within 30 days before first dose, except injectable inactivated influenza vaccine
- Pregnant or lactating women
- Serious or uncontrolled systemic diseases including severe heart abnormalities, unstable angina, recent arterial thrombosis, poor blood pressure control, active lung diseases, infections, liver diseases, poorly controlled diabetes, significant proteinuria, mental disorders preventing cooperation
- Any other condition or history that may interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
L
Li Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here