Actively Recruiting
A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Sun Jing · Updated on 2025-08-08
30
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.
CONDITIONS
Official Title
A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Pathologically confirmed squamous esophageal cancer of the thoracic segment
- Locally advanced disease without distant metastasis, clinical stage cT2-4aN+ or cT3-4aN0, M0, stage II, III, or IVA (AJCC 8th edition)
- ECOG performance status score of 0-1
- No prior anti-tumor treatments such as radiotherapy, chemotherapy, or immunotherapy
- Expected survival greater than 6 months
- Adequate organ function including white blood cells, neutrophils, platelets, hemoglobin, liver and kidney function, and cardiac function (grade 1-2)
- Controlled blood pressure with antihypertensive medication if hypertensive
- Controlled fasting blood glucose (≤8 mmol/L) with medication if diabetic
- No serious diseases like autoimmune disorders, immunodeficiency, organ transplantation, or ongoing hormone therapy
- No history of other malignant tumors
- Willingness to participate and signing informed consent
You will not qualify if you...
- Previous anti-tumor therapy including chemotherapy, radiotherapy, surgery, or immunotherapy
- Presence of other incurable malignant tumors except certain cured skin tumors, cervical cancer in situ, or prostate cancer
- Significant risk or history of esophageal perforation, fistula, or hemorrhage
- Active autoimmune or immunodeficiency diseases or use of immunosuppressants including prednisone doses ≥10 mg/day for more than 2 weeks
- Significant cardiovascular disease such as recent severe heart attack, unstable angina, heart failure, arrhythmia needing treatment, or low left ventricular ejection fraction (<50%)
- Severe allergies
- Pregnancy or breastfeeding
- Severe mental disorders
- Presence of peripheral nerve disease grade 3 or higher
- Abnormal blood clotting or bleeding tendencies or use of blood thinners
- Severe lung diseases including fibrosis, pneumonia, pneumoconiosis, impaired lung function, or active tuberculosis within 1 year
- Active hepatitis B or C infection
- Any other condition judged by the investigator to make the participant ineligible for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
J
Jing Sun
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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