Status:
UNKNOWN
A Study of Second-line Treatment With Apatinib After TACE in Advanced Hepatocellular Carcinoma Patients
Lead Sponsor:
Peking University Cancer Hospital & Institute
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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-mont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02727309
Start Date
October 1 2015
End Date
March 1 2019
Last Update
April 4 2016
Active Locations (1)
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1
Department of Interventional Therapy
Beijing, Beijing Municipality, China, 100142