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Hepatic Neoplasm Malignant RecurrentPhase 3NCT01640808

Study of Peretinoin for Suppressing Recurrence of HCV-positive HCC

A Phase 3 study testing NIK-333(peretinoin) in people with Hepatic Neoplasm Malignant Recurrent, run by Kowa Company, Ltd. at 66 sites in Japan.

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 purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatic Neoplasm Malignant Recurrent
What is being tested?
NIK-333(peretinoin)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
616 participants
Where
66 sitesJapan
Study dates
Apr 2012to Nov 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with HCV-positive HCC who meet the following conditions before radical treatment
  • Patients diagnosed as having typical HCC on dynamic CT,CTA/CTAP, or dynamic MRI (nodule visualized as a high signal intensity area in the arterial phase and as a relatively low signal intensity area in the portal and equilibrium phases) performed within 8 weeks (56 days) before treatment start prior to radical therapy
  • Patients with the first primary HCC or the first recurrence of primary HCC
  • Patients who received the radical therapies. The treatment duration (from the start to the end of the treatment) should be within 4 weeks (28 days) for each of the radical therapies.
  • Patients showing a complete cure, as confirmed by the dynamic CT images taken from 8 weeks (56 days) to 12 weeks (84 days) after the end of the treatment show a non-stained low-concentration area overlapping the tumor image observed before complete cure.
  • Patients who are able to begin treatment with the study drug within 8 weeks (56 days) after dynamic CT to confirm complete cure
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  • Patients confirmed of satisfying the following conditions based on the screening performed at subject registration
  • Positive for serum hepatitis C virus nucleic acid (HCV-RNA)
  • Grade A on Child-Pugh classification
  • Platelet count of 50 000/µL or higher
  • Patients with ECOG Performance Status score of 0 to 1
  • Patients of the age of 20 years or older at the time of informed consent

Who cannot join

  • Patients positive for HBs antigen
  • Patients showing vascular invasion of HCC on imaging diagnosis
  • Patients who have also undergone transcatheter arterial embolization therapy (TAE/TACE), transarterial infusion therapy (TAI), and chemolipiodolization in combination with the radical therapy
  • 4 Patients who want to receive antiviral therapy such as concomitant therapy with intaferon during the study period
  • Patients who have received other study drugs, anticancer drugs, or interferons after radical therapy
  • Patients who have hypertension as a complication, and whose blood pressure cannot be controlled by drug therapy (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, as determined at subject registration)
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  • Patients who have a history of allergy to CT contrast media, and whose participation in this study is judged to be inappropriate by the investigator or the subinvestigator
  • Patients with a history of total gastrectomy
  • Patients with a history of cardiac arrest
  • Patients with any of the following laboratory values or complications
  • Creatinine>= 1.5mg/dL
  • Albumin urine >= 1000mg/g Creatinine
  • Cardiac disorder corresponding to CTC-AE grade 3 in severity
  • HbA1c >= 7.4 under treatment with insulin
  • Autoimmune disease or asthma being treated with oral steroid
  • Patients confirmed of having another malignant neoplasm or who had undergone a radical therapy of HCC within the past 5 years to treat another malignant neoplasm (however, this does not apply to endoscopic resection and resection of intraepithelial carcinoma)
  • Patients who are pregnant, who have a possibility of being pregnant or who have a desire to become pregnant during the study period
  • Lactating women
  • Patients who have a history of allergy to retinoid-related substances (vitamin A, etc.) in the past
  • Patients who participated in another clinical study within past 6 months

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

Japan66 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-0021

  • Study site

    Bunkyo-ku, Tokyo, 113-8655

  • Study site

    Bunkyo-ku,, Tokyo, 113-8519

  • Study site

    Chiba, 260-0856

  • Study site

    Chiyoda-ku, Tokyo, 101-8643

  • Study site

    Chuo-ku, Tokyo, 104-0045

  • Study site

    Fukuoka, 810-8563

  • Study site

    Fukuoka, 814-0180

  • Study site

    Gifu, 500-8513

  • Study site

    Gifu, 501-1194

  • Study site

    Himeji, Hyōgo, 670-0063

  • Study site

    Hiroshima, 734-8530

  • Study site

    Hiroshima, 734-8551

  • Study site

    Iizuka, Fukuoka, 820-0018

  • Study site

    Ikeda, Osaka, 563-8510

  • Study site

    Iruma, Saitama, 350-0495

  • Study site

    Kagoshima, 890-8520

  • Study site

    Kanazawa, Ishikawa-ken, 920-8641

  • Study site

    Kashiwa, Chiba, 277-8577

  • Study site

    Kawasaki, Kanagawa, 213-8587

  • Study site

    Kobe, Hyōgo, 650-0047

  • Study site

    Kofu, Yamanashi, 400-8506

  • Study site

    Kumamoto, 860-0811

  • Study site

    Kurashiki, Okayama-ken, 701-0192

  • Study site

    Kurume, Fukuoka, 830-0011

  • Study site

    Matsuyama, Ehime, 790-0826

  • Study site

    Minato-ku, Tokyo, 105-8470

  • Study site

    Moriguchi, Osaka, 570-8507

  • Study site

    Musashino, Tokyo, 180-8610

  • Study site

    Nagasaki, 852-8501

  • Study site

    Nagoya, Aichi-ken, 466-0065

  • Study site

    Nagoya, Aichi-ken, 467-0001

  • Study site

    Nankoku, Kochi, 783-8505

  • Study site

    Niigata, 950-1104

  • Study site

    Nishinomiya, Hyōgo, 663-8501

  • Study site

    Ōgaki, Gifu, 503-0864

  • Study site

    Ōita, 879-5593

  • Study site

    Okayama, 700-8558

  • Study site

    Osaka, 534-0021

  • Study site

    Osaka, 537-8511

  • Study site

    Osaka, 540-0006

  • Study site

    Osaka, 543-8555

  • Study site

    Osaka, 545-8586

  • Study site

    Ōta-ku, Tokyo, 143-8541

  • Study site

    Saga, 840-8571

  • Study site

    Saga, 849-8501

  • Study site

    Sagamihara, Kanagawa, 228-8520

  • Study site

    Sagamihara, Kanagawa, 252-0375

  • Study site

    Sakai, Osaka, 591-8025

  • Study site

    Sapporo, Hokkaido, 006-8555

  • Study site

    Sapporo, Hokkaido, 060-0033

  • Study site

    Sapporo, Hokkaido, 060-8648

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Setagaya-ku, Tokyo, 158-8531

  • Study site

    Shibuya-ku, Tokyo, 150-8935

  • Study site

    Shimonoseki, Yamaguchi, 750-0061

  • Study site

    Shimotsuke, Tochigi, 329-0498

  • Study site

    Shinjuku-ku, Tokyo, 160-0023

  • Study site

    Suita, Osaka, 565-0871

  • Study site

    Sunto-gun, Shizuoka, 411-8777

  • Study site

    Tokushima, 770-8503

  • Study site

    Tokushima, 770-8539

  • Study site

    Ube, Yamaguchi, 755-8505

  • Study site

    Wakayama, 641-8510

  • Study site

    Yokohama, Kanagawa, 232-0024

  • Study site

    Yokohama, Kanagawa, 241-0815

Other trials in Japan

About this study

Official title: NIK-333(Peretinoin) PhaseⅢ Study Investigation of the Efficacy and Safety to Suppress Recurrence of Hepatitis C Virus(HCV)-Positive Hepatocellular Carcinoma(HCC), Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group Study

The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study.

Being tested
NIK-333(peretinoin), Placebo

What participants receive

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

  • NIK-333(peretinoin)Drug

    600mg (8 x 75mg capsules) orally, twice a day

  • PlaceboDrug

    Placebo (8 x Placebo capsules) orally, twice a day

Study groups in NCT01640808
Study groupRoleWhat they receive
NIK-333(peretinoin)ExperimentalNot described
Receives: Drug: NIK-333(peretinoin)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Recurrence-free Survival

    HCC recurrence was defined as the appearance of new intrahepatic lesions which was confirmed based on findings of hypervascularity (nodules enhanced in the arterial phase and washout in the late phase) by dynamic CT images, or a new extrahepatic metastasis. Recurrence of intrahepatic HCC was evaluated by an independent image reading committee.

    RFS was defined as the time from randomization to HCC recurrence or death from any cause, whichever occurred first. For subjects who terminated the study without HCC recurrence or death, RFS was censored at the day of the latest dynamic CT examination.

    Measured: Date of randomization to the date of recurrence of HCC (followed every 12 weeks) or death (whichever occurs first)

Secondary outcomes (2)

  1. Disease-free Survival

    DFS was defined as the time from randomization to HCC recurrence, death from any cause or occurrence of secondary cancer (malignant tumors other than HCC), whichever occurred first. For subjects who terminated the study without HCC recurrence, death, or occurrence of secondary cancer, DFS was censored at the day of the latest dynamic CT examination.

    Measured: Date of randomization to the date of recurrence of HCC (followed every 12 weeks), death, or secondary cancer (malignant tumors other than HCC)(whichever occurs first)

  2. Time to Recurrence

    TTR was defined as the time from randomization to HCC recurrence. For subjects who terminated the study without HCC recurrence, TTR was censored at the day of the latest dynamic CT examination.

    Measured: Date of randomization to the date of recurrence of HCC(followed every 12 weeks)

Timeline

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

  1. First posted16 Jul 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionOct 2016
  4. Study completionNov 2016

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
616 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01640808
Sponsor's protocol ID
NIK-333-05
Status last verified
Nov 2020
First submitted
10 Jul 2012
Last updated
2 Dec 2020

Publications

  • Qin XY, Shirakami Y, Honda M, Yeh SH, Numata K, Lai YY, Li CL, Wei F, Xu Y, Imai K, Takai K, Chuma M, Komatsu N, Furutani Y, Gailhouste L, Aikata H, Chayama K, Enomoto M, Tateishi R, Kawaguchi K, Yamashita T, Kaneko S, Nagaoka K, Tanaka M, Sasaki Y, Tanaka Y, Baba H, Miura K, Ochi S, Masaki T, Kojima S, Matsuura T, Shimizu M, Chen PJ, Moriwaki H, Suzuki H. Serum MYCN as a predictive biomarker of prognosis and therapeutic response in the prevention of hepatocellular carcinoma recurrence. Int J Cancer. 2024 Aug 1;155(3):582-594. doi: 10.1002/ijc.34893. Epub 2024 Feb 21.

    PubMed 38380807

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NIK-333(peretinoin) in people with Hepatic Neoplasm Malignant Recurrent, run by Kowa Company, Ltd. at 66 sites in Japan.

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 12 inclusion and 20 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Japan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recurrence-free Survival (time frame: Date of randomization to the date of recurrence of HCC (followed every 12 weeks) or death (whichever occurs first)). 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 NCT01640808, which also lists 1 linked publication.

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 2 Dec 2020.

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