A Study of Second-line Treatment With Apatinib After TACE in Advanced Hepatocellular Carcinoma Patients

NCT ID: NCT02727309

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-03-31

Brief Summary

This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib

Patients with advanced hepatocellular carcinoma after been treated with TACE receive apatinib (750mg) daily, until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib: 750 mg is administered orally daily, until disease progression or untolerable toxicity.

Interventions

Apatinib

Apatinib: 750 mg is administered orally daily, until disease progression or untolerable toxicity.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with a histologic or cytologic diagnosis of hepatocellular carcinoma
• Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment
• The previous chemotherapy and the present trial registration must be at least 2 weeks apart. And they must have recovered from any toxicity of a previous chemotherapy
• Patients with Child Pugh Class A & B disease are eligible for the study
• Patients with Barcelona Clinic Liver Cancer stage B or C are eligible for the study
• Eastern Cooperative Oncology Group performance score (PS): 0-2
• Life expectancy of at least 12 weeks
• Hepatitis B virus DNA<2000 IU/ml
• Adequate organ function meeting the following:

• Bone marrow: absolute neutrophil count ≥1.5×109/L (1500/mm3); platelet ≥ 75×109/L; hemoglobin ≥9 g/dL
• Liver: Serum bilirubin ≤ 1.5 ×ULN, AST and ALT ≤ 5 ×ULN, ALB ≥ 29 g/L
• Kidney: Cr ≤1.5 ×upper limit of normal
• Within 7 days prior to the start of therapy, women of child-bearing potential must undergo a pregnancy test, which must be negative; men of child-bearing potential: contraceptive measures must be adopted during treatment and within 8 weeks afterward
• Subjects who understand and voluntarily signed a written informed consent form

Exclusion Criteria

• Previous locoregional therapy within 4 weeks prior to enrollment
• Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma
• History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
• Prepared for liver transplantation
• Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
• A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence
• Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
• Patients with central nervous system metastases or brain metastasis
• Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia
• Pregnant or lactating women
• Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Zhuxu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xu Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Department of Interventional Therapy

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xu Zhu, MD

Role: CONTACT

drzhuxu@163.com

+86-10-88196476

Facility Contacts

Xu Zhu, MD

Role: primary

drzhuxu@163.com

+86-10-88196476

Other Identifiers

AHEAD-HBH001

Identifier Type: -

Identifier Source: org_study_id