Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.
| Condition(s) | Esophageal Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer. |
| Who can participate | Inclusion Criteria: 1. Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC). 2. Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition). 3. Age: 18-75 years old. 4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. PD-L1 Expression: Available PD-L1 expression level (CPS). 6. Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon. 7. Laboratory Requirements: * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, Platelets ≥ 100 x 10\^9/L, Hemoglobin ≥ 9 g/dL. * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN. * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Fujian Medical University Union Hospital |
| Locations | Fuzhou, Fujian, China |
| Start date | 2024-07-11 |
| NCT ID | NCT06601309 |
| Official listing | https://clinicaltrials.gov/study/NCT06601309 |