Status:
UNKNOWN
Apatinib in the Treatment of Metastatic Colorectal Cancer
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03403452
Start Date
January 1 2018
End Date
December 31 2019
Last Update
January 18 2018
Active Locations (1)
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1
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai, China, 200032