Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Neoadjuvant Becotatug vedotin plus Pucotenlimab (3 cycles)
Sponsors
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Fully understood the study and voluntarily signed the informed consent form (ICF). The ICF must be signed prior to the performance of any study-specific procedures. 2.Age 18–70 years (inclusive), of any gender; 3.Histologically confirmed esophageal squamous cell carcinoma (ESCC). 4.Pre-treatment clinical stage II–III (cT2N0-1M0, cT3N0-1M0, cT1-3N2M0) according to the AJCC/UICC 8th edition; 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6.Adequate cardiac function. All patients must undergo an electrocardiogram (ECG); patients with a history of heart disease or ECG abnormalities must undergo an echocardiogram, demonstrating a Left Ventricular Ejection Fraction (LVEF) > 50%; 7. Have sufficient bone marrow and liver and kidney organ functions. The laboratory tests within 7 days before the first administration should meet the following requirements: a. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelets >= 100 × 10^9/L, and hemoglobin >= 90 g/L (no blood transfusion, blood products, or use of granulocyte colony-stimulating factor or other hematopoietic stimulating factors to correct within 14 days before the laboratory test); b. Serum total bilirubin = 50 mL/min (calculated using the Cockcroft-Gault formula, see Appendix 2); e. Urinalysis shows urine protein = 2+, 24-hour urine protein quantification should be = 6 months; 9.Women of childbearing potential (WOCBP) must have a confirmed negative serum pregnancy test within 7 days prior to enrollment and agree to use effective contraceptive measures during the study drug administration period and for 2 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with other malignant tumors within 5 years prior to the first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, radically resected carcinoma in situ, and/or papillary thyroid carcinoma. 2.Presence of symptomatic or clinically significant thyroid dysfunction at screening (patients with hypothyroidism that can be controlled with thyroid hormone replacement therapy alone may be included). 3.Use of immunosuppressants within 4 weeks prior to the first dose, excluding intranasal, inhaled, or other topical glucocorticoids, or systemic glucocorticoids at physiological doses. 4.Presence of any active autoimmune disease requiring systemic treatment or a history of autoimmune disease within the past 2 years; known history of primary immunodeficiency. 5.Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting (CABG) within 6 months prior to the first dose; Congestive heart failure New York Heart Association (NYHA) class = 2; Left ventricular ejection fraction (LVEF) 38.5°C) occurring during the screening period or prior to the first dose; 7.Patients with active tuberculosis (TB), currently receiving anti-tuberculosis treatment, or who have received anti-tuberculosis treatment within 1 year prior to the first dose. 8.History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe impairment of lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity; Positive screening for Human Immunodeficiency Virus (HIV) antibodies. 9.Known history of clinically significant liver disease, including active viral hepatitis infection: For Hepatitis B: if Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) are positive, HBV DNA > 1 × 10^3 copies/mL or > 200 IU/mL; For Hepatitis C: known Hepatitis C Virus (HCV) antibody positive with HCV RNA > 1 × 10^3 copies/mL; Or other hepatitis, or clinically significant moderate-to-severe liver cirrhosis. 10.Known hypersensitivity to any component of the Becotatug vedotin or Pucotenlimab formulations, or a history of severe hypersensitivity reactions to any other monoclonal antibodies. 11.Other reasons that, in the opinion of the investigator, make the patient unsuitable for participation in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate;Adverse Event/Reaction;R0 resection;Major Pathological response;Serious Adverse Event/Reaction;2-year Disease-Free Survival (DFS) rate; | — |
Countries
China
Contacts
Public ContactXuan Xie
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed