A Study of KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment in Patients With Advanced Esophageal Cancer

Exclusion Criteria1

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis; Other malignancies within the past 5 years; Known hypersensitivity to any monoclonal antibodies or chemotherapy components; Gastrointestinal abnormalities; High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula; Cardiovascular and cerebrovascular diseases; Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1; Active autoimmune disease or a history of autoimmune disease requiring systemic treatment; Active infections, including severe infection (CTCAE \> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV; Pregnant or lactating women; Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study; Other conditions assessed by the investigator that would increase safety risks or interfere with the study results.