Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental arm:Sacituzumab Tirumotecan Combined with Adebrelimab
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Age 18–75 years at the time of signing the informed consent form, with no gender restriction. 2)Histologically or pathologically confirmed esophageal squamous cell carcinoma (ESCC). 3)Resectable locally advanced thoracic esophageal squamous cell carcinoma assessed by CT/MRI/EUS, etc. (AJCC clinical stage: Stage II–IVA, T2-4aNxM0). 4)No prior anti-tumor therapy of any kind, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine. 5)Expected to achieve R0 resection. 6)Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1. 7)No contraindications to surgery. 8)Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor administration within 2 weeks before the first dose), defined as follows: a) Hematology: Absolute neutrophil count (NEUT#) = 1.5×10?/L; platelet count (PLT) = 100×10?/L; hemoglobin = 90 g/L.b) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5×ULN; for subjects with baseline liver metastases, ALT and AST = 5×ULN; albumin = 30 g/L; total bilirubin (TBIL) = 1.5×ULN.c) Renal function: Creatinine clearance = 50 mL/min (calculated using the standard Cockcroft-Gault formula).d) Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) = 1.5×ULN. 9)Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraception from the time of signing informed consent until 6 months after the last dose. 10)Subjects are voluntarily willing to participate in this study, have signed the informed consent form, and are able to comply with the study visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1)Participation in another clinical trial of an investigational medicinal product within 4 weeks prior to enrollment. 2)Obvious tumor invasion of adjacent organs (major arteries or trachea) of the esophageal lesion. 3)History of other malignant tumors within 5 years prior to enrollment, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 4)Known history of hypersensitivity to the study drugs (lucotuzumab vedotin/adebrelimab) or any of their components. 5)Presence of supraclavicular lymph node metastasis. 6)Refractory pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 7)Positive human immunodeficiency virus (HIV) test result or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 8)History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 9)Vaccination with a live attenuated vaccine within 30 days prior to the first study drug administration. 10)History of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring corticosteroid therapy; current ILD or non-infectious pneumonia; or suspected ILD or non-infectious pneumonia at screening that cannot be ruled out by imaging tests. Severe clinical pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy. 11)History of active autoimmune diseases requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., type 1 diabetes mellitus, hypothyroidism requiring only levothyroxine replacement therapy, adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy). 12)Active infection requiring systemic treatment within 2 weeks prior to the first study drug administration. 13)Concomitant diseases that, in the investigator’s judgment, seriously endanger the patient’s safety or affect the patient’s ability to complete the study, including but not limited to poorly controlled hypertension, severe diabetes mellitus, and active infections refractory to medical management. 14)Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal diseases that may hinder or delay corneal wound healing. 15)Pregnant or lactating women; female patients of childbearing potential with a positive baseline pregnancy test; female patients of childbearing potential who are unwilling to use effective contraception during the study drug treatment period and within 6 months after the last dose. 16)Any other conditions that, in the investigator’s judgment, make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) Rate;R0 resection rate;Event-Free Survival (EFS);Overall Survival (OS);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactXiaolong Yan
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed