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

Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Apatinib

• Registration Number: NCT02727309
• Lead Sponsor: Peking University Cancer Hospital & Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-03
• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-03-30
• Study First Posted: 2016-04-04
• Last Update Posted: 2016-04-04
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival	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	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.

Trial Locations

Locations (1)

Department of Interventional Therapy; 🇨🇳 Beijing, Beijing, China