A Study of Anlotinib in Patients With Hepatocellular Carcinoma (ALTER0802)

September 4, 2016 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Aiping Zhou, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Anlotinib
Anlotinib p.o. qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12-week Progression-free survival rate(PFR 12w)
Time Frame: From randomization，each 42 days up to PD or death(up to 24 months)
From randomization，each 42 days up to PD or death(up to 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death (up to 24 months)
From randomization until death (up to 24 months)
Objective Response Rate (ORR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Time to Progression(TTP)
Time Frame: From randomization，each 42 days up to PD or death(up to 24 months)
From randomization，each 42 days up to PD or death(up to 24 months)
24-week Progression-free survival rate(PFR 24w)
Time Frame: From randomization，each 42 days up to PD or death(up to 24 months)
From randomization，each 42 days up to PD or death(up to 24 months)
Serum Alpha-Fetoprotein level (AFP)
Time Frame: From randomization up to 24 months
From randomization up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 4, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-08-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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