AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2ALTER0802NCT02809534

A Study of Anlotinib in Patients With Hepatocellular Carcinoma

A Phase 2 study testing Anlotinib in people with Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To assess the primary effects and safety of Anlotinib with placebo in patients with Hepatocellular Carcinoma(HCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Sep 2016to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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：
Show all 17Show fewer
  • Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
  • 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);
  • Patients with active or unable to control serious infections;
  • Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
  • 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

Trial locations and contacts

1 site in 1 country.

Aiping Zhou, doctor contact

zhouap1825@126.com

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Aiping Zhou, doctor

    Recruiting

Other trials in China

About this study

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)

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

Being tested
Anlotinib
Keywords
Anlotinib, AL3818
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02809534
Study groupRoleWhat they receive
AnlotinibExperimentalAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: Anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-week Progression-free survival rate(PFR 12w)

    Measured: From randomization，each 42 days up to PD or death(up to 24 months)

Secondary outcomes (6)

  1. Time to Progression(TTP)

    Measured: From randomization，each 42 days up to PD or death(up to 24 months)

  2. 24-week Progression-free survival rate(PFR 24w)

    Measured: From randomization，each 42 days up to PD or death(up to 24 months)

  3. Serum Alpha-Fetoprotein level (AFP)

    Measured: From randomization up to 24 months

  4. Overall Survival (OS)

    Measured: From randomization until death (up to 24 months)

  5. Objective Response Rate (ORR)

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  6. Disease Control Rate (DCR)

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02809534
Sponsor's protocol ID
ALTN-08-II
Acronym
ALTER0802
Status last verified
Sep 2016
First submitted
20 Jun 2016
Last updated
7 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib in people with Hepatocellular Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aiping Zhou, doctor (zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-week Progression-free survival rate(PFR 12w) (time frame: From randomization，each 42 days up to PD or death(up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02809534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in