Status:
UNKNOWN
Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery for Locally Advanced ESCC (KEYSTONE-001)
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Stage III
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced esophageal squa...
Detailed Description
The Preoperative chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a...
Eligibility Criteria
Inclusion
- Histologically confirmed esophageal squamous cell carcinoma;
- Potentially resectable cT3N1M0，cT1-3N2M0(stage III)(AJCC 8 TNM classification);
- Have a performance status of 0 or 1 on the ECOG Performance Scale;
- Age 18-70 years old, both men and women;
- Be willing and able to provide written informed consent/assent for the trial;
- Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to 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 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) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
Exclusion
- Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer;
- Ineligibility or contraindication for esophagectomy;
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
- Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04389177
Start Date
July 8 2020
End Date
December 31 2024
Last Update
April 10 2023
Active Locations (1)
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1
Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060