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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02727309
• Other study ID #: AHEAD-HBH001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 28, 2016
• Last updated: March 30, 2016
• Start date: October 2015
• Est. completion date: March 2019

Study information

• Verified date: March 2016
• Source: Beijing Cancer Hospital
• Contact: Xu Zhu, MD
• Phone: +86-10-88196476
• Email: drzhuxu[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Department of Interventional Therapy	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.	6 months	No
Secondary	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	No
Secondary	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	No