Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC)

Tianjin Medical University

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03046979

AHEAD-HBH002

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC.

Full description

Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go.

At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of our previous clinical studies, we intends to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Before doing any research steps, the patient's informed consent must be obtained first.

2. The diagnosis of HCC: histologic diagnosis or Alpha fetoprotein (AFP) with two kinds of imaging diagnosis.

3. Patients of Barcelona stage(BCLC) C with first-line treatment failure or non tolerance to sorafenib.

4. Ages of 18 to 75 years old.

5. Child-Pugh score between 5-7 points, patients of Child-Pugh 7 points should be without ascites.

6. Eastern Cooperative Oncology Group performance score (ECOG PS) is 0-1 point.

7. Adequate organ function meeting the following:

   Hemoglobin(HBG)≧9.0g/dl Neutrophil count(ANC) ≧1,500/mm3 Platelet count(PLT)≧50,000/ul Total bilirubin (TBIL)< 2mg/dL (3mg/dL, Child-Pugh B) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 5×ULN (upper limit of normal) ALP (alkaline phosphatase ) < 4×ULN PT (prothrombin time) >50% or PT-INR<2.3, <6 seconds or greater than that of the control

8. For patients taking warfarin, at least once a week to a close monitoring of the patients, until, according to the standard of treatment, at every time of medication, the subjects' INR measurements has been stable

9. SCr (serum creatinine) <1.5×ULN

10. For pregnant women, the results of serum pregnancy tests must be negative within 14 days before initiation of treatment.

11. All men and women who participated in the study had to take reliable contraceptive measures within the trial and two weeks of after the trial.

Exclusion criteria

1. Patients of Child-Pugh 7 has serious uncontrolled ascites.
2. Patients with serious cardiovascular disease.
3. Patients with high blood pressure of unable to control.
4. Patients has the history of HIV (human immunodeficiency virus) infection.
5. Active clinical severe infection (> 2, NCI-CTCAE version 3).
6. Need to drug treatment of patients with epilepsy (such as steroid or antiepileptic drugs)
7. Has a history of allogeneic organ transplantation.
8. Patients with a history of physical signs or have a bleeding.
9. Patients undergoing renal dialysis.
10. Metastatic liver cancer.
11. Patients with uncontrollable ascites.
12. Patients with encephalopathy.
13. Patients has history of gastrointestinal bleeding period of 30 days before join the study.
14. Patients with a history of esophagus varicosity burst hemorrhage, then not effective treatment or therapy to prevent recurrence of bleeding.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Apatinib

Experimental group

Description:

a molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.

Treatment:

Drug: Apatinib