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OncoMatch/Clinical Trials/NCT04807673

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

Is NCT04807673 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Pembrolizumab and Paclitaxel for esophageal squamous cell carcinoma.

Phase 3RecruitingTianjin Medical University Cancer Institute and HospitalNCT04807673Data as of May 2026

Treatment: Pembrolizumab · Paclitaxel · CisplatinThe 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.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage CT1-3N1-2M0, CT2-3N0M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: operation

Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer

Cannot have received: radiotherapy

Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer

Cannot have received: immunotherapy

Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer

Cannot have received: chemotherapy

Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer

Cannot have received: chemotherapy

Patient has received prior chemotherapy, radiotherapy, target therapy ,and immune therapy for this malignancy or any other past malignancy

Cannot have received: radiotherapy

Patient has received prior chemotherapy, radiotherapy, target therapy ,and immune therapy for this malignancy or any other past malignancy

Cannot have received: target therapy

Patient has received prior chemotherapy, radiotherapy, target therapy ,and immune therapy for this malignancy or any other past malignancy

Cannot have received: immune therapy

Patient has received prior chemotherapy, radiotherapy, target therapy ,and immune therapy for this malignancy or any other past malignancy

Lab requirements

Blood counts

Kidney function

Liver function

Demonstrate adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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