Digestive System Tumors Clinical Trial
Official title:
A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients With Advanced Recurrent or Metastatic Digestive System Tumors
The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.
Status | Recruiting |
Enrollment | 133 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | |
China | The first affiliated hospital of bengbu medical college | Bengbu | |
China | Chongqing University Three Gorges Hospital | Chongqing | |
China | Fujian Cancer Hospital | Fujian | |
China | Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University | Henan | |
China | The First Affiliated Hospital of Xinxiang Medical University | Henan | |
China | Hubei Cancer Hospital | Hubei | |
China | Union Hospital Tongji Medical College Huazhong University of Science and Technologe | Hubei | |
China | Shandong Cancer Hospital & Institute | Shandong | |
China | Shanghai Chest Hospital | Shanghai | |
China | Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center | Shenzhen | |
China | Tianjin Medical University Cancer Institute &Hospital | Tianjin | |
China | The Second Affiliated Hospital Zhejiang University School of Medicine | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Beijing Konruns Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1. | approximately 2 year. | |
Secondary | Progression-free survival (PFS) | Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause. | approximately 2 year | |
Secondary | Disease Control Rate (DCR) | Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1. | approximately 2 year. | |
Secondary | Duration of Response (DOR) | Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1. | approximately 2 year. | |
Secondary | Pharmacokinetics (PK) profile: Cmax | Parameters: Peak Plasma Concentration | approximately 2 year. | |
Secondary | Pharmacokinetics (PK) profile: Tmax | Parameters: Time to reach the maximum plasma concentration | approximately 2 year. | |
Secondary | Pharmacokinetics (PK) profile: T1/2 | Parameters: Terminal half-life | approximately of 2 year. | |
Secondary | Pharmacokinetics (PK) profile: AUC | arameters: Area under the single-dose plasma concentration-time curve. | approximately of 2 year. | |
Secondary | Adverse events (AEs) | Incidence of treatment-related AEs | approximately of 2 year. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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