A Study of Anlotinib in Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— ALTER0802  

Official title:

A Single Group, Open Label, Single-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Hepatocellular Carcinoma (ALTER0802)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02809534
• Other study ID #: ALTN-08-II
• Status: Recruiting
• Phase: Phase 2
• First received: June 20, 2016
• Last updated: September 4, 2016
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: Aiping Zhou, doctor
• Email: zhouap1825[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the primary effects and safety of Anlotinib with placebo in patients with Hepatocellular Carcinoma(HCC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of hepatocellular carcinoma who cannot benefit from treatments of ablative therapy

• Liver function status Child-Pugh Class A or B (score=8)

• Enroll 2 group patients:Group A:No history of systematic chemotherapy/target therapy.Group B:Failed with Sorafenib(Last Sorafenib Therapy=4 weeks )

• Last Therapy=4 weeks (such as surgery, PCI,ablation, radiotherapy),and the wound healing.Patients with adjuvant chemotherapy, last chemotherapy =6m

• At least one measurable lesion (by RECIST1.1)

• 18-75 years,ECOG PS:0-1,Life expectancy of more than 3 months

• Main organs function is normal

• Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device,contraceptive and condom) throughout treatment and for at least 6 months after study is stopped;the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment,and the patients required to be non-lactating;Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped

• Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

• Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma

• History of other malignancy (except for non-melanoma skin cancer, cervix in situ carcinoma)

• Liver function status Child-Pugh Class C (score>9),with malignant ascites

• HBV-DNA>2000IU/mL

• History of liver transplantation or prepare for it

• Patients with any severe and/or unable to control diseases,including:

1. Blood pressure unable to be controlled ideally(systolic pressure=150 mmHg,diastolic pressure=100 mmHg);

2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT=480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);

3. Patients with active or unable to control serious infections;

4. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)

5. Urine protein = ++,and 24-hour urinary protein excretion>1.0 g confirmed

• Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism

• Patients with drug abuse history and unable to get rid of or Patients with mental disorders

• Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage

• Patients participated in other anticancer drug clinical trials within 4 weeks

• History of immunodeficiency

• Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-week Progression-free survival rate(PFR 12w)		From randomization,each 42 days up to PD or death(up to 24 months)	No
Secondary	Time to Progression(TTP)		From randomization,each 42 days up to PD or death(up to 24 months)	No
Secondary	24-week Progression-free survival rate(PFR 24w)		From randomization,each 42 days up to PD or death(up to 24 months)	No
Secondary	Serum Alpha-Fetoprotein level (AFP)		From randomization up to 24 months	No
Secondary	Overall Survival (OS)		From randomization until death (up to 24 months)	No
Secondary	Objective Response Rate (ORR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)	No
Secondary	Disease Control Rate (DCR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)	No