Clinical trial NCT02727309: A Study of Second-line Treatment With Apatinib After TACE in Advanced Hepatocellular Carcinoma Patients
Official title: A Pilot Study of Second-line Treatment With Apatinib After Trans Arterial Chemoembolization (TACE) in Advanced Hepatocellular Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Apatinib
Second-line Treatment
Hepatocellular Cancer
TACE
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2016-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Objective response rates
timeFrame: 1.5 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Interventional Therapy
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Xu Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: