To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors

This is an interventional treatment trial for Digestive System Tumors Read More

Inclusion Criteria:

• Histologically or cytologically confirmed malignant digestive system tumors;
• Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• BMI≥18.0;
• Has adequate Hematologic, renal, and hepatic function;
• Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

• Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms;
• Other kinds of malignancies;
• Gastrointestinal abnormalitiest;
• Cardiovascular and cerebrovascular diseases;
• Previous treatment with small molecule vascular targeting inhibitor；
• Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment;
• Involved in other clinical trials within 4 weeks before enrollment;
• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment;
• Uncontrolled massive ascites,pleural/pericardial effusion;
• Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (> 38.5 ℃) occurred within 2 weeks before enrollment;
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection ;
• Pregnant or lactating women or those who do not take contraceptives, including men;
• Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
• Inability to comply with protocol required procedures.