A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer

Inclusion Criteria:

• Males or females aged 18 to 75 years;
• Histologically or cytologically confirmed esophageal or esophageal-gastric junctionsquamous cell carcinoma;
• Patient with advanced recurrent or metastatic esophageal squamous cell carcinomapreviously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemictherapy;
• At least one measurable tumor lesion according to RECIST 1.1;
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• BMI≥16.0 and weight≥40 kg ;
• Adequate bone marrow, renal, and hepatic function;
• Female patients of childbearing potential with a negative blood pregnancy testcompleted within 7 days before randomization；
• Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

• Any patient who is known to have untreated central nervous system (CNS) metastasis;
• Other kinds of malignancies within 5 years;
• Gastrointestinal abnormalities;
• Cardiovascular and cerebrovascular diseases;
• Prior therapies with vascular targeting inhibitor；
• Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil OteracilPotassium；
• Involved in other clinical trials within 4 weeks before enrollment；Prior anti-tumortherapies with radiotherapy, immunotherapy, operation within 4 weeks beforeenrollment;Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumortherapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer)before enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having notresolved to NCI CTCAE 5.0 Grade 0 or 1;
• Uncontrolled massive ascites, pleural or pericardial effusion;
• Severe infection within 4 weeks prior to randomization (CTCAE > Grade 2);
• Known history of human immunodeficiency virus (HIV) infection or current activehepatitis B or C infection;
• Pregnant or lactating women;
• Female subjects of child-bearing potential and male subjects of reproductive capacitywho do not agree to use contraceptive measures during the study and for 6 months afterthe end of the study.
• Other patients are not eligible for enrollment assessed by investigators.