Actively Recruiting
Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
Led by Tongji University · Updated on 2024-03-13
25
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study
CONDITIONS
Official Title
Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with resectable stage II or III esophageal squamous cell carcinoma
- No prior anti-tumor treatment for esophageal squamous cell carcinoma
- Age between 18 and 75 years
- No surgical contraindications based on organ function evaluations
- Sufficient bone marrow, liver, and kidney function as shown by laboratory tests
- No history of chemotherapy, radiation, hormone therapy for malignant tumors, except prostate cancer patients with disease-free survival over 5 years after hormone therapy
- Expected to achieve complete tumor removal (R0 resection)
- Physical health status ECOG 0-1
- Able to understand and sign informed consent
You will not qualify if you...
- Previous treatment for esophageal cancer including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- Not suitable for surgery or having surgical contraindications
- Prior treatment with anti PD-L1/PD-1 therapies
- Immunodeficiency or long-term steroid or immunosuppressive therapy within 7 days before study drug
- Active autoimmune diseases requiring systemic treatment within 2 years
- Poorly controlled heart disease
- Pregnant or breastfeeding women
- Known allergies to drugs used in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
J
Jiang Fan, MD
CONTACT
F
Fu Yang, DM
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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