Clinical trial NCT01192971: A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma
Official title: Randomized, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Keywords: HCC, Apatinib, phase II, Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Eighty-One Hospital of People's Liberation Army
First posted: 2010-09-01
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase II trial will be studying how well Apatinib working in patients with Hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologic confirmed advanced hepatocellular carcinoma
* Patients who are unable to or unwilling to undergo surgery or interventional procedures via hepatic artery, or patients who have relapsed/progressed after surgery or interventional procedure via hepatic artery for ≥ 4 weeks and are unable to use sorafenib.
* Life expectancy of more than 12 weeks.
* ECOG performance scale 0 - 2.
* Child -Pugh score A，BCLC stage B or C.
* At least one therapy naïve measurable lesion (larger than 10 mm in diameter by spiral CT scan, conforming to RECIST 1.1).
* Have not received systemic chemotherapy or molecular targeted therapy. At least 4 weeks must have elapsed for patients who have previously underwent radiotherapy or surgery, and all the adverse drug reactions (ADRs) or wounds have completely healed. At least 6 months must have elapsed for patients who have received adjuvant chemotherapy.
* Adequate organ functions (hemoglobin≥ 90g/L ,platelets ≥80 × 109/L, neutrophil≥ 1.5 × 109/L, albumin ≥ 29 g/L, Plasma creatinine ≤ 1.5 × ULN , ALT and AST\< 5 × ULN; TBIL ≤ 1.5 × ULN.
* Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma; other malignancies previously or currently, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
* Dysphagia, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption.
* Evidence of CNS metastasis.
* Subjects with hypertension which cannot be well controlled by antihypertensives; grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and cardiac insufficiency grades III to IV according to NYHA criteria; cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) of \< 50%.
* Subjects with abnormal coagulation functions, and the tendency of bleeding or those who are currently treated by a thrombolytic or anticoagulant therapy.
* Definite concern of gastrointestinal hemorrhage, and history of gastrointestinal hemorrhage within 6 months.
* Patients with symptomatic ascites requiring therapeutic paracentesis or drainage, or with a Child-Pugh score of ≥ 2.

Primary outcomes:
measure: TTP (Time to Progression)
timeFrame: 8 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: 8 weeks
measure: DCR (Disease control rate
timeFrame: 8 weeks
measure: ORR (objective response rate)
timeFrame: 8 weeks
measure: Serum alpha-fetoprotein (AFP) level
timeFrame: 8 weeks
measure: QoL (quality of life): EORTC QLQ-C30
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Millitary Eighty-one Hosiptal
state: Jiangsu
Study officials:
affiliation: Nanjing Millitary Eighty-one Hosiptal
name: Shukui Qin, Dr
role: PRINCIPAL_INVESTIGATOR
References: