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OncoMatch/Clinical Trials/NCT06304350

Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

Is NCT06304350 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Combination of pembrolizumab and platinum containing dual drugs for esophageal cancer.

Phase 2RecruitingTongji UniversityNCT06304350Data as of May 2026

Treatment: Combination of pembrolizumab and platinum containing dual drugsThis study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage II, III

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: chemotherapy

Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors

Cannot have received: radiation therapy

Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors

Cannot have received: hormone therapy

Exception: except prostate cancer patients who have received hormone therapy and have obtained DFS for more than 5 years

Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors, have no history of other malignant tumors, and do not include prostate cancer patients who have received hormone therapy and have obtained DFS for more than 5 years

Cannot have received: immunotherapy

Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.)

Cannot have received: targeted therapy

Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.)

Cannot have received: anti-PD-1 therapy

Have a history of other anti PD-L1/PD-1 treatments

Lab requirements

Blood counts

Hemoglobin ≥ 9.0g/L; WBC 4.0-10 × 10^9/L; ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Prothrombin time ≤ 1.5x ULN, some prothrombin time within normal range

Kidney function

Creatinine ≤ 1.5x ULN

Liver function

Total bilirubin ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN

hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 10^9/L; Neutrophil absolute value (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit of normal values, and some prothrombin time is within the normal range; Creatinine ≤ 1.5 times the upper limit of normal value

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

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