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.
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.
Check if I qualifyExtracted 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
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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