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OncoMatch/Clinical Trials/NCT06907602

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

Is NCT06907602 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Chemotherapy and Immunotherapy (Pembrolizumab) for locally advanced esophageal squamous cell carcinoma.

Phase 2/3RecruitingPeking Union Medical College HospitalNCT06907602Data as of May 2026

Treatment: Chemotherapy · Immunotherapy (Pembrolizumab)Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage RESECTABLE T4

Endoscopic ultrasound, enhanced CT scan...evaluate as T3 or resectable T4...evaluation of N0 or N+; No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a); T staging evaluation is T1/T2 [excluded]; PET/CT and other evaluations show distant metastasis (M1) [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: chemotherapy

History of previous chemotherapy

Cannot have received: radiation therapy

History of previous...radiation therapy

Cannot have received: immunotherapy

History of previous...immunotherapy

Cannot have received: stem cell transplant

Previously received stem cell or solid organ transplantation

Cannot have received: solid organ transplant

Previously received stem cell or solid organ transplantation

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 11g/L

Kidney function

Creatinine clearance rate (Cockroft) ≥ 50ml/min

Liver function

ALT ≤ 2 times the upper limit of normal value; TBil ≤ 1.5 times the upper limit of normal value

No hematological diseases, no liver or kidney dysfunction; Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 11g/L; ALT ≤ 2 times the upper limit of normal value; TBil ≤ 1.5 times the upper limit of normal value; Creatinine clearance rate (Cockroft) ≥ 50ml/min

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

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