Apatinib in the Treatment of Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.

Official Title
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A Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed After Standard Second Line Therapy

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arm for Apatinib<br>500 mg,p.o.,qd | Drug: Apatinib<br>* 500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS（progress free survival） | PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause | From assignment of the first subject to 3 months later after the last participant is recruited | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS（overall survival） | OS is defined as the time from date of assignment to death due to any cause | From assignment of the first subject until 30 death events observed, up to 2 years | 
| ORR（objective response rate） | The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR) | From assignment of the first subject to 3 months later after the last participant is recruited | 
| DCR（disease control rate) | 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) | From assignment of the first subject to 3 months later after the last participant is recruited |