Actively Recruiting
Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2022-06-01
342
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin as neoadjuvant therapy followed by surgery, and pembrolizumab as adjuvant therapy, compared with neoadjuvant chemoradiotherapy and surgery for locally advanced ESCC in multicenter.
CONDITIONS
Official Title
Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed esophageal squamous cell carcinoma
- R0 resectable thoracic esophageal cancer, cT1-3N1-2M0 or cT2-3N0M0 (AJCC V8 TNM classification)
- No suspicious metastatic lymph nodes on the clavicle
- ECOG performance status of 0 or 1
- Age 18 to 75 years, men and women
- Willing and able to provide written informed consent
- Adequate organ function
- Negative pregnancy test within 72 hours before first study medication dose for females of childbearing potential
- Willing to provide tissue, blood, and urine samples with tissue obtained up to 4 weeks before treatment
- No prior systemic or local treatment for esophageal cancer
You will not qualify if you...
- Ineligibility or contraindication for esophagectomy
- Prior therapy for esophageal cancer including surgery, radiotherapy, immunotherapy, or chemotherapy
- Active or history of autoimmune disease
- Need for systemic corticosteroids or other immunosuppressive medications
- History of symptomatic interstitial lung disease
- Allergy to study drug components
- Pregnant or breastfeeding women
- Prior chemotherapy, radiotherapy, targeted therapy, or immune therapy for this or any other malignancy
- Underlying medical conditions that may make study drug administration unsafe or interfere with toxicity assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
H
Hongjing Jiang, MD,PhD
CONTACT
X
Xiaobin Shang, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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