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

Overview

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.

Full Title of Study: “A Pilot Study of Second-line Treatment With Apatinib After Trans Arterial Chemoembolization (TACE) in Advanced Hepatocellular Carcinoma Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Progression free survival
    • Time Frame: 6 months
    • A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.

Secondary Measures

  • Overall survival
    • Time Frame: 2 years
    • Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause
  • Objective response rates
    • Time Frame: 1.5 months
    • Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 6 weeks following the date of the initial response.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University Cancer Hospital & Institute
  • Collaborator
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhuxu, Principal Investigator – Peking University Cancer Hospital & Institute
  • Overall Official(s)
    • Xu Zhu, MD, Principal Investigator, Peking University Cancer Hospital & Institute
  • Overall Contact(s)
    • Xu Zhu, MD, +86-10-88196476, drzhuxu@163.com

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