Clinical trial NCT03403452: Apatinib in the Treatment of Metastatic Colorectal Cancer
Official title: A Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed After Standard Second Line Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2018-01-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: PFS（progress free survival）
timeFrame: From assignment of the first subject to 3 months later after the last participant is recruited
Secondary outcomes:
measure: OS（overall survival）
timeFrame: From assignment of the first subject until 30 death events observed, up to 2 years
measure: ORR（objective response rate）
timeFrame: From assignment of the first subject to 3 months later after the last participant is recruited
measure: DCR（disease control rate)
timeFrame: From assignment of the first subject to 3 months later after the last participant is recruited
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Zhongshan Hospital, Fudan University
Study officials:
References: