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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Department of Interventional Therapy
      • Contact: Xu Zhu, MD; Phone Number: +86-10-88196476; Email: drzhuxu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: apatinib; Patients with advanced hepatocellular carcinoma after been treated with TACE receive apatinib (750mg) daily, until disease progression or unacceptable toxicity.	Drug: Apatinib; Apatinib: 750 mg is administered orally daily, until disease progression or untolerable toxicity.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause	2 years
Objective response rates	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.	1.5 months

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: XU zhu, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Apatinib; TACE; Second-line Treatment; Hepatocellular Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Ahead-HBH001