Actively Recruiting
Efficacy and Safety Study of Paclitaxel Polymeric Micelles, Cisplatin, and Cadonilimab as Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Sun Jing · Updated on 2025-08-08
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new neoadjuvant treatment combining Cadonilimab, a PD-1/CTLA-4 bispecific antibody, with platinum-based chemotherapy (Paclitaxel Polymeric Micelles for Injection and Cisplatin) for patients with locally advanced esophageal squamous cell carcinoma. This Phase 2 clinical trial aims to measure pathologic complete remission rates after 2 to 4 treatment cycles, alongside other measures like objective remission rate, major pathologic remission rate, surgical removal rate, and 2-year survival outcomes. Participants receive Cadonilimab intravenously at 10 mg/kg on day 3 every 3 weeks, combined with Paclitaxel Polymeric Micelles administered intravenously (230 mg/m2 for cycle 1; possibly increased to 260 mg/m2 for cycles 2-4 depending on blood counts and side effects) and Cisplatin intravenously at 25 mg/m2 daily for 3 days every 3 weeks. Treatment lasts approximately 12 weeks, covering 2 to 4 cycles before surgery. Throughout the study, participants undergo regular assessments including pathological evaluation after surgery to determine remission, as well as monitoring of overall and progression-free survival over 2 years. Safety and organ function are closely observed, with eligibility requiring adequate heart, liver, kidney, and blood function. Participants are followed from treatment initiation through surgery and beyond to evaluate clinical outcomes and side effects.
CONDITIONS
Brief 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
- Confirmed squamous esophageal cancer in the thoracic segment by pathology
- Locally advanced, resectable or potentially resectable esophageal cancer without distant metastasis, clinical stage cT2-4aN+ or cT3-4aN0, M0, stage II, III, or IVA
- ECOG performance status of 0 or 1
- No prior antitumor treatments including chemotherapy, radiotherapy, or immunotherapy
- Expected survival time greater than 6 months
- Adequate organ function: sufficient white blood cells, neutrophils, platelets, hemoglobin, liver enzymes within limits, creatinine clearance above 40 ml/min, and no serious heart disease
- Controlled blood pressure using antihypertensive drugs if needed
- Controlled fasting blood glucose at or below 8 mmol/L with diabetes medication if applicable
- No serious diseases that conflict with the study, such as autoimmune diseases, immunodeficiency, or organ transplantation
- No history of other malignant tumors
- Must agree to participate and sign 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 or in situ cancers
- Risk or presence of esophageal perforation, fistula, or hemorrhage
- Active autoimmune or immunodeficiency diseases or use of immunosuppressants above 10 mg/day prednisone for more than 2 weeks
- Significant cardiovascular diseases such as recent severe heart attack, unstable angina, heart failure, arrhythmias, or low heart function
- Severe allergies
- Pregnant or breastfeeding women
- Severe mental disorders
- Peripheral nerve disease grade 3 or higher
- Abnormal blood clotting or current anticoagulant therapy
- Severe lung diseases or active tuberculosis within one year
- Active hepatitis B or C infection
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive Paclitaxel Polymeric Micelles, Cisplatin, and Cadonilimab as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.
Treatment cycles every 3 weeks for up to 4 cycles
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
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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