Actively Recruiting
Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Shanghai Zhongshan Hospital · Updated on 2025-12-05
26
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Shanghai Zhongshan Hospital
Lead Sponsor
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.
CONDITIONS
Official Title
Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily joined the study, can sign informed consent, and have good compliance
- Age 18 years or older
- ECOG score between 0 and 1
- Diagnosed with operable esophageal squamous cell carcinoma confirmed by pathology and imaging
- Clinical TNM stage T2-4aNxM0
- Assessed as needing routine neoadjuvant therapy
- No prior immunotherapy, chemotherapy, targeted therapy, or radiotherapy
- Expected survival of at least 12 weeks
You will not qualify if you...
- Active or history of autoimmune diseases including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, uncontrolled thyroid dysfunction, or requiring long-term thyroid hormone replacement after surgery; vitiligo or childhood asthma in remission without intervention are allowed; asthma requiring bronchodilators is excluded
- Previous or concurrent malignant tumors
- Previous systemic anti-tumor therapy
- Major surgery, open biopsy, or serious injury within 28 days before treatment; ongoing wounds or fractures not healed
- Risk of bleeding, coagulation disorders, or current thrombolytic therapy; history of esophageal or gastric variceal bleeding within 6 months
- Known allergy to large molecule protein drugs or study drug ingredients
- Severe or uncontrolled illnesses
- Ascites or pleural effusion requiring therapeutic drainage
- History of substance abuse, alcoholism, or drug use
- Other factors judged by researchers that may cause study termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Di Ge, MD
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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