A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma (HCC)

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: Apatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01192971

HENGRUI20100510

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

A: 850mg

Experimental group

Description:

A: Experimental apatinib 850 mg qd p.o, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Drug: Apatinib

B: 750mg

Experimental group

Description:

B: Apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Drug: Apatinib