Status:
COMPLETED
A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsors:
Eighty-One Hospital of People's Liberation Army
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This phase II trial will be studying how well Apatinib working in patients with Hepatocellular carcinoma.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01192971
Start Date
June 1 2010
End Date
July 1 2013
Last Update
March 3 2023
Active Locations (1)
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1
Nanjing Millitary Eighty-one Hosiptal
Nanjing, Jiangsu, China, 210002