Colorectal Cancer
Conditions
Brief summary
This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.
Interventions
DRUGApatinib
500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 and ≤ 80 years of age * Histological confirmed advanced or metastatic colorectal cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT * Have failed for ≥ 2 lines of chemotherapy and/or targeted therapy * Life expectancy of more than 3 months * ECOG performance scale 0～1 * Duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents * Adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 ×10\^9/L, neutrophil \> 1.5 × 10\^9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin \< 1.5 ULN, and serum transaminase ≤ 2.0× ULN) * Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. * Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
* Prior VEGFR inhibitor treatment within 2 weeks * History of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy * More than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency * Pregnant or lactating women * Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * URT: urine protein ≥ (++)and \> 1.0 g of 24 h * PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation * Certain possibility of gastric or intestine hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS（progress free survival） | From assignment of the first subject to 3 months later after the last participant is recruited | PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS（overall survival） | From assignment of the first subject until 30 death events observed, up to 2 years | OS is defined as the time from date of assignment to death due to any cause |
| ORR（objective response rate） | From assignment of the first subject to 3 months later after the last participant is recruited | The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR) |
| DCR（disease control rate) | From assignment of the first subject to 3 months later after the last participant is recruited | DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD) |
Countries
China
Contacts
Primary ContactJianmin Xu, PhD
Outcome results
None listed