A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

Advanced Hepatocellular Carcinoma Clinical Trial

— HCC  

Official title:

Randomized, Open-label, Multi-center, Phase II Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192971
• Other study ID #: HENGRUI20100510
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: February 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Apatinib
apatinib p.o. once daily for 4 weeks

Locations

Country	Name	City	State
China	Nanjing Millitary Eighty-one Hosiptal	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	Eighty-One Hospital of People's Liberation Army

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TTP (Time to Progression)		8 weeks
Secondary	Overall Survival		8 weeks
Secondary	DCR (Disease control rate		8 weeks
Secondary	ORR (objective response rate)		8 weeks
Secondary	Serum alpha-fetoprotein (AFP) level		8 weeks
Secondary	QoL (quality of life): EORTC QLQ-C30		8 weeks