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Hepatocellular Carcinoma (HCC)Phase 2NCT01972672

The Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma

A Phase 2 study testing Icaritin in people with Hepatocellular Carcinoma (HCC), run by Beijing Shenogen Biomedical Co., Ltd at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to assess the time to progression (TTP) in patients with advanced HCC treated with Icaritin . Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Icaritin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
3 sitesChina
Study dates
Oct 2013to Mar 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

  • Patients may be entered in the study only if they meet all of the following criteria:
  • The age is between 18 and 75.
  • Patients who have HCC which should be histologically or cytologically confirmed. At least one lesion, not previously treated ( can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography (CT) per RECIST 1.1)
  • Patients who cannot accept or is not willing to have surgery or any interventional therapy via hepatic artery, or had surgery and any Interventional therapy via hepatic artery more than 4 weeks with disease progression, and cannot tolerate Sorafenib or Oxaliplatin doublet chemotherapy or cannot use or refused to use them
  • Child-Pugh status A or B (≤7) ( Either albumin or haemachrome is >2)
  • ECOG PS: 0 or 1.
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  • Patients who have a life expectancy of at least 12 weeks.
  • Patients who have not received chemotherapy and target therapy. If patients received radiation therapy or surgery, the treatment should be at least 4 weeks prior to enrollment and any AE and wounds during the treatment should be recovered. If patient received adjuvant chemotherapy, the treatment should be at least 6 months prior to enrollment.
  • Meet following laboratory parameters:
  • Haematology ( no blood transfusion or Blood products or Hematopoietic growth factor within 14 days)
  • Hemoglobin ≥ 90 g/dL
  • Neutrophil cell count≥1.5 × 10^9/L
  • Platelet count ≥ 80 × 10^9/L
  • Clinical chemistry,
  • Albumin ≥ 29 g/dL (no albumin transfusion or blood product within 14 days)
  • ALT and AST < 5 × ULN
  • Total bilirubin ≤ 1.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN
  • If HBV-DNA≥10^4, anti-virus therapy should be used until HBV-DNA< 10^4
  • Patients is willing to participate in the study with good compliance and must have given written informed consent prior to any study specific screening
  • Patients who did not participate in any other study 4 weeks prior to enrollment and all adverse events occurs before should be recovered.

Who cannot join

  • Patients who meet with any below criterion should not be included in the study:
  • Previously known intrahepatic cholangiocarcinoma, mixed cell carcinoma and fibrolamellar carcinoma; previous or concurrent malignant tumor (healed skin basal cell carcinoma and carcinoma in situ of uterine cervix are not included);
  • Women in pregnancy or lactation;
  • Patients who have hypertension and blood pressure are not well controlled after treatments with antihypertensive drugs (systolic pressure > 150mmHg, diastolic pressure >100mmHg); patients who have grade II or higher myocardial ischemia or myocardial infarction and poorly controlled arrhythmia (including QTC interval≥ 450ms) and grade III-IV cardiac insufficiency according to NYHA criteria; Ultrasound Cardiogram on heart: LVEF (left ventricular ejection fraction)<50%;
  • Patients are incapable of swallow, or have chronic diarrhea or intestinal obstruction, which significantly affects administration and absorption of study drug;
  • Patients potentially have gastrointestinal hemorrhage (such as local active ulcer foci, occult blood in stools ++ or even higher), previous medical records of alimentary tract hemorrhage within six months;
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  • Patients who have central nervous system metastasis;
  • Patients who have coagulation disorder (prothrombin time > 16s, activated partial thromboplastin time > 43s, thrombin time >21s, fibrinogen< 2g/L), subjects showing hemorrhagic tendency or accepting thrombolytic or anticoagulant therapy;
  • Patients who have psychiatric disorders or previous medical history of psychotropic drug abuse;
  • Patients who have seroperitoneum with clinical symptoms, requring remedial abdominal paracentesis or drainage, or Child-Pugh score ≥2.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Cancer institute & hospital, chinese academy of medical sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Shenogen Biomedical Co., Ltd

    Beijing, Beijing Municipality, 102206

  • NanJing PLA 81 Hospital

    Nanjing, Jiangsu, 210002

Other trials in China

About this study

Official title: An Open-label,Single-arm Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma

The primary objective of the study is to assess the time to progression (TTP) in patients with advanced HCC treated with Icaritin .

Read the detailed description

Icaritin is a newly discovered small molecular compound which is high selective ERa36 modulators ,the preclinical PK\&PD and toxicity studies showed it can inhibit the growth of HCC cancer cells both in vitro and in vivo, combining clinical data perhaps it will be a very promising new drug to treat hepatocellular carcinoma (HCC) by targeting this nongenomic pathway. Shenogen decided to further investigate the efficacy and safety of Icaritin and to explore potential gene targets for treating HCC.

The results of phase I study showed Icaritin has good safety and tolerance. The biological availability of Icaritin after meal is high and the half-life is relatively short.

The phase Ib study enrolled 28 subjects. Among the 18 HCC subjects, 12 subjects received treatment in the oral administration group with 600 mg once, twice per day, after meal 30 minutes, 6 subjects received treatment in the oral administration group with 800 mg once, twice per day, after meal 30 minutes. The results showed that in the 600mg group there are 12 HCC patients whose therapeutic efficacy is evaluable now, one case of PR (10%), 5 cases of SD (50%) and 4 cases of PD (40%) were observed.Safety data showed that totally 24 AEs are probably related to investigational drug. Among them, 19 AEs are grade I, 5 AEs are grade II, no grade III or above AE.

Being tested
Icaritin
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • IcaritinDrug

    Also called SNG-162

    Icaritin 600 mg orally, twice daily for a total daily dose of 1200 mg

Study groups in NCT01972672
Study groupRoleWhat they receive
IcaritinExperimentalIcaritin 600 mg orally, twice daily for a total daily dose of 1200 mg
Receives: Drug: Icaritin

What is being measured

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

  1. time to progress（TTP）

    The study will be an open-label, single-armed study to evaluate the clinical benefit of Icaritin 600 mg twice daily with oral administration for total of 1200 mg daily added to Best Supportive Care in patients with advanced HCC.

    Measured: 1-2 years

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the date of the first dose of study drug to first documentation of objective disease progression or to death on study due to any cause, whichever occurs first. It will be analyzed in the same way as TTP.

    Measured: 1-2 years

  2. Overall survival (OS)

    OS: This is defined as the time from the date of first study dose to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis will be censored at the date of the last follow up assessment. Patients without follow up assessment will be censored at the day of last dose and patients with no post baseline information will be censored at the time of first study dose. Overall survival is defined as the length of time from first dose of treatment until death. It will be analyzed in the same way as TTP.

    Measured: 1-2 years

  3. Overall response rate (ORR) (proportion of patients with confirmed partial and complete responses)

    ORR: it is defined as the percentage of the patients achieving remission (including PR and CR) of tumors during treatment or within 30 days after the initiative treatment as confirmed by the RECIST1.1.

    Measured: 1-2 years

  4. Overall disease control rate (DCR)

    DCR: during first-line therapy is defined as SD for 8 weeks or longer, CR plus PR as determined by the RESIST 1.1 criteria for patients with measurable disease.

    Objective response rate and disease control rate will be determined along with 95% confidence intervals.

    Measured: 1-2 years

  5. Assessment on Quality of life

    The descriptive analysis will be used for the data from quality of life questionnaire (EORTC QLQ-C30 V3.0 and HCC-18).

    Measured: 1-2 years

  6. Type, incidence, severity, seriousness and relationship to study drug of adverse events (AEs) and serious adverse events (SAEs);

    To assess the safety and tolerability of Icaritin in patients with advanced hepatocellular carcinoma

    Measured: 1-2 years

  7. Laboratory abnormal findings

    To assess the safety and tolerability of Icaritin in patients with advanced hepatocellular carcinoma

    Measured: 1-2 years

Timeline

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

  1. First posted30 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionAug 2015
  4. Study completionMar 2017

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01972672
Sponsor's protocol ID
QU1305ICR
Status last verified
Jan 2021
First submitted
14 Oct 2013
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Icaritin in people with Hepatocellular Carcinoma (HCC), run by Beijing Shenogen Biomedical Co., Ltd at 3 sites 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 21 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to progress（TTP） (time frame: 1-2 years). 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 NCT01972672.

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 27 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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