To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors

Launched by BEIJING KONRUNS PHARMACEUTICAL CO., LTD. · Feb 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KC1036 for patients with advanced digestive system tumors, which are cancers that affect parts of the digestive tract. The goal is to find out how well KC1036 works, how safe it is, and how the body processes it. The trial is currently looking for participants who have already tried standard treatments for their cancer but did not see improvement. Eligible patients should have confirmed malignant tumors and be in relatively good health, with a life expectancy of more than 12 weeks.

If you decide to participate, you will receive KC1036 and be monitored closely for any side effects or changes in your condition. The trial is open to adults aged 18 and older, and we welcome individuals of all genders. However, certain health conditions, such as active infections or other serious diseases, may prevent you from joining. It's important to understand that participation is voluntary, and you will need to sign a consent form to take part. This trial represents an opportunity to explore a potential new treatment option for those with limited choices.

Gender

ALL

Eligibility criteria

• 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.