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

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Apatinib

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