Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)

Prior treatment

• Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
• Requiring systemic treatment with either corticosteroids or other immunosuppressive medications;
• Patient has received prior chemotherapy, radiotherapy, target therapy ，and immune therapy for this malignancy or any other past malignancy;

Other illness

• Active autoimmune disease or history of autoimmune disease;
• Subjects with a history of symptomatic interstitial lung disease;
• History of allergy to study drug components;
• 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.

Other

• Ineligibility or contraindication for esophagectomy;
• Women must not be pregnant or breast-feeding;

• 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.