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

NCT02727309 | Unknown Phase 1

• 1 other identifier: AHEAD-HBH001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Apatinib; Second-line Treatment; Hepatocellular Cancer; TACE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

  2 years

• Objective response rates

  1.5 months

Study Arms (1)

apatinib

EXPERIMENTAL

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

Drug: Apatinib

Interventions

Apatinib DRUG

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

apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Department of Interventional Therapy

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Xu Zhu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Zhu, MD

CONTACT

+86-10-88196476; drzhuxu@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 4, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

CN (1)