A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma (HCC)

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing Millitary Eighty-one Hosiptal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: 850mg; A: Experimental apatinib 850 mg qd p.o, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Apatinib; apatinib p.o. once daily for 4 weeks
Experimental: B: 750mg; B: Apatinib 750 qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Apatinib; apatinib p.o. once daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TTP (Time to Progression)	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
DCR (Disease control rate	8 weeks
ORR (objective response rate)	8 weeks
Overall Survival	8 weeks
Serum alpha-fetoprotein (AFP) level	8 weeks
QoL (quality of life): EORTC QLQ-C30	8 weeks

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborators: Eighty-One Hospital of People's Liberation Army
• Investigators: Principal Investigator: Shukui Qin, Dr, Nanjing Millitary Eighty-one Hosiptal

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: HCC, Apatinib, phase II, Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: HENGRUI20100510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No