Patients with resectable locally advanced esophageal squamous cell carcinoma (clinical stage III-IVa)
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 18 to 75 years old, and who have signed the informed consent form; 2.Patients with newly diagnosed esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology); 3.Clinical stage cT1b-cT2, N+, M0 or cT2-cT4a, any N, M0, according to the UICC/AJCC TNM staging system (8th edition, 2017), and deemed by the investigator as suitable for radical esophagectomy requiring neoadjuvant therapy before surgery; 4.ECOG (Eastern Cooperative Oncology Group) performance status score: 0-2; 5.Normal function of major organs, with sufficient organ function before the first drug use (no use of any blood components, cell growth factors, leukocyte-elevating drugs, platelet-elevating drugs, etc. within 7 days before laboratory tests); • Blood routine: Absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >=75 g/L; • Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =28 g/L; • Renal function: Serum creatinine (Cr) =50 mL/min (using the standard Cockcroft-Gault formula); urine protein =2+, 24-hour urine protein quantification is required, and patients with 24-hour urine protein <1.0 g can be enrolled); • Coagulation function: Activated partial thromboplastin time (APTT) <= 1.5×ULN, international normalized ratio (INR) <= 1.5, prothrombin time (PT) <= 1.5×ULN. 6.Able to comply with the study protocol as judged by the investigator; 7.Negative pregnancy test at screening (for female patients of childbearing potential); 8.Male patients of childbearing potential and female patients with childbearing potential and pregnancy risk must agree to use contraception throughout the study period; 9.Patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1.Patients who have previously received surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy for esophageal squamous cell carcinoma; 2.Patients with distant organ metastasis; 3.Patients with esophageal squamous cell carcinoma who have had active bleeding from the primary lesion within 2 months; patients with tumors that may invade the bronchus or major blood vessels and have a bleeding tendency. 4.Patients who have received systemic corticosteroids (more than 10 mg prednisone or equivalent per day) or other immunosuppressive agents (including but not limited to cyclophosphamide, methotrexate, thalidomide, etc.) within 14 days before the first drug administration, or are expected to require such treatment during the study period. However, physiological doses of corticosteroids (i.e., 150 mmHg and/or diastolic blood pressure >100 mmHg) and considered clinically significant by the investigator; b) History of hypertensive crisis or hypertensive encephalopathy; c) History of intracranial or spinal hemorrhage; d) Current evidence of bleeding tendency or severe coagulopathy (without anticoagulant therapy) or tumor involvement of major blood vessels; e) Hemoptysis within 1 month before the first dose (each episode with >= 1/2 teaspoon of bright red blood) or a history of gastrointestinal bleeding that is deemed ineligible by the investigator; f) Current evidence of free abdominal air; g) Current presence of severe, non-healing, or open wounds, or untreated fractures; h) Any other disease that, in the investigator's judgment, may lead to an unacceptable risk of adverse events during the study treatment. 7.Subjects with any of the following cardiovascular diseases are excluded. a) Myocardial infarction, unstable angina, pulmonary embolism, acute/sustained myocardial ischemia, cerebrovascular accident, transient ischemic attack, or other clinically significant/medication-requiring arteriovenous thromboembolic or ischemic events within 6 months before the first drug administration; b) Past and/or current NYHA class III~IV congestive heart failure; c) Past and/or current severe arrhythmia requiring drug treatment; d) Mean QT interval (QTcF) >470 ms on 12-lead ECG before the first drug administration. 8.Concomitant tumors in other organs; 9.Acute or chronic hepatitis B or C virus infection; 10.HIV-positive patients; those who have received antituberculosis treatment within one year before the first study treatment; HBsAg-positive individuals with HBV DNA >= 2000 IU/ml or 104 copies/ml; HCV antibody-positive individuals with positive HCV RNA. 11.Known active tuberculosis; known active
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR;OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;R0 removal rate;TRG;Safety; | — |
Countries
China
Contacts
Public ContactJie Luo
The Second Affiliated Hospital of Guangxi Medical University
Outcome results
None listed