Efficacy and Safety of Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-001)

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country50 target enrollmentJuly 8, 2020

ConditionsEsophageal Squamous Cell Carcinoma Stage III

InterventionsPembrolizumab Injection [Keytruda]

DrugsPembrolizumab Injection [Keytruda]

Overview

Phase: Phase 2
Intervention: Pembrolizumab Injection [Keytruda]
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: Major pathologic response
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 squamous cell carcinoma.

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 single-arm, open-label, phase II trial of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced (stage III) esophageal squamous cell cancer. The purpose of this study is to observe and evaluate the efficacy and safety.

Registry

clinicaltrials.gov

Start Date

July 8, 2020

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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 Criteria

•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.