A Study of Apatinib in Patients With Advanced Hepatocellu... | NCT01192971

NCT01192971

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Eighty-One Hospital of People's Liberation Army	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A: 850mg	Experimental	A: Experimental apatinib 850 mg qd p.o, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Apatinib
B: 750mg	Experimental	B: Apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Apatinib

Name	Type	Description	Arm Group Labels	Other Names
Apatinib	Drug	apatinib p.o. once daily for 4 weeks	A: 850mg B: 750mg

Measure	Description	Time Frame
TTP (Time to Progression)		8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologic confirmed advanced hepatocellular carcinoma
Patients who are unable to or unwilling to undergo surgery or interventional procedures via hepatic artery, or patients who have relapsed/progressed after surgery or interventional procedure via hepatic artery for ≥ 4 weeks and are unable to use sorafenib.
Life expectancy of more than 12 weeks.
ECOG performance scale 0 - 2.
Child -Pugh score A，BCLC stage B or C.
At least one therapy naïve measurable lesion (larger than 10 mm in diameter by spiral CT scan, conforming to RECIST 1.1).
Have not received systemic chemotherapy or molecular targeted therapy. At least 4 weeks must have elapsed for patients who have previously underwent radiotherapy or surgery, and all the adverse drug reactions (ADRs) or wounds have completely healed. At least 6 months must have elapsed for patients who have received adjuvant chemotherapy.
Adequate organ functions (hemoglobin≥ 90g/L ,platelets ≥80 × 109/L, neutrophil≥ 1.5 × 109/L, albumin ≥ 29 g/L, Plasma creatinine ≤ 1.5 × ULN , ALT and AST< 5 × ULN; TBIL ≤ 1.5 × ULN.
Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

Pregnant or lactating women.
Patients with known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma; other malignancies previously or currently, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
Dysphagia, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption.
Evidence of CNS metastasis.
Subjects with hypertension which cannot be well controlled by antihypertensives; grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and cardiac insufficiency grades III to IV according to NYHA criteria; cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) of < 50%.
Subjects with abnormal coagulation functions, and the tendency of bleeding or those who are currently treated by a thrombolytic or anticoagulant therapy.
Definite concern of gastrointestinal hemorrhage, and history of gastrointestinal hemorrhage within 6 months.
Patients with symptomatic ascites requiring therapeutic paracentesis or drainage, or with a Child-Pugh score of ≥ 2.