Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Single arm:Nimotuzumab? Sintilimab and Neoadjuvant Chemotherapy
Sponsors
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. Aged 18 to 75, male or female; 3. Patients with esophageal squamous cell carcinoma confirmed by histology or cytology; 4. ECOG performance status: 0–1; 5. No previous treatment targeting the primary esophageal tumor, including medication, surgery, or radiotherapy; 6. Clinical stage: cT1-2,N1-3,M0 or cT3-4a,N0-3,M0 (AJCC/UICC Esophageal Cancer Staging, 8th edition), and eligible for surgical resection; 7. Major organ function meeting the following requirements: a. Absolute neutrophil count >= 1.5×10^9/L, platelets >= 80×10^9/L, hemoglobin >= 90 g/L; b. Total bilirubin = 60 ml/min (Cockroft-Gault formula); d. Serum albumin >= 28 g/L; e. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= lower limit of normal (50%); f. Pulmonary function: FEV1/FVC >= 70%, FEV1 >= 50% of normal, DLCO (lung diffusion capacity) measured value > 80% of predicted value. 8. Women of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before enrollment; and must not be breastfeeding. Male patients must agree to use contraception during the study and for 6 months after the study period.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism); 2. Patients currently using immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent steroid), and still using them within 2 weeks before enrollment; 3. Patients who have previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors; 4. Patients with any severe and/or uncontrolled disease, including: a. patients with poorly controlled blood pressure (systolic >=150 mmHg or diastolic >=100 mmHg), myocardial ischemia or infarction above Grade I, arrhythmias (including QT interval >=480 ms), heart failure Grade I or above; b. active or uncontrolled severe infections; c. liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >=10^4 copies/ml or 2000 IU/ml) or hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the assay); 5. Patients whose imaging shows tumor invasion of major vessels/trachea or who are judged by the investigator to have a high risk of fatal events during subsequent study periods; 6. Pregnant or breastfeeding women; 7. Patients with other malignancies within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 8. Patients with a history of substance abuse of psychiatric drugs who cannot abstain or patients with psychiatric disorders; 9. Patients who have participated in another drug clinical trial within 4 weeks; 10. Patients with comorbidities that, in the investigator’s judgment, pose serious safety risks or affect completion of the study; 11. Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary response rate;Event-free survival; | — |
Countries
China
Contacts
Public ContactYongkun Sun
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed