A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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This phase II trial will be studying how well Apatinib working in patients with Hepatocellular carcinoma.

Official Title
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Randomized, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

Conditions
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Advanced Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: 850mg<br>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<br>* apatinib p.o. once daily for 4 weeks<br>|
| Experimental: B: 750mg<br>B: Apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Apatinib<br>* apatinib p.o. once daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTP (Time to Progression) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 8 weeks | 
| DCR (Disease control rate |  | 8 weeks | 
| ORR (objective response rate) |  | 8 weeks | 
| Serum alpha-fetoprotein (AFP) level |  | 8 weeks | 
| QoL (quality of life): EORTC QLQ-C30 |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, Apatinib, phase II, Cancer