Status:
RECRUITING
Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Shanghai Chest Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Preoperative chemoradiotherapy with radical surgery is the recommended treatment for locally advanced esophageal squamous cell carcinoma (ESCC) in the NCCN guidelines. But many patients refused or aba...
Eligibility Criteria
Inclusion
- Histologically confirmed esophageal squamous cell carcinoma;
- R0 resectable thoracic esophageal cancer, cT1-3N1-2M0, cT2-3N0M0 (AJCC V8 TNM classification);
- No suspicious metastatic lymph nodes on the clavicle;
- Have a performance status of 0 or 1 on the ECOG Performance Scale;
- Age 18-75 years old, both men and women;
- Be willing and able to provide written informed consent/assent for the trial;
- Demonstrate adequate organ function ;
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
- Be willing to provide tissue, blood, and urine samples. Tissue should be from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) before initiation of treatment on Day 1.
- Have not received systemic or local treatment for esophageal cancer in the past.
Exclusion
- Ineligibility or contraindication for esophagectomy;
- Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
- Active autoimmune disease or history of autoimmune disease;
- Requiring systemic treatment with either corticosteroids or other immunosuppressive medications;
- Subjects with a history of symptomatic interstitial lung disease;
- History of allergy to study drug components;
- Women must not be pregnant or breast-feeding;
- Patient has received prior chemotherapy, radiotherapy, target therapy ，and immune therapy for this malignancy or any other past malignancy;
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT04807673
Start Date
December 1 2021
End Date
May 1 2028
Last Update
June 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060