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Advanced Hepatocellular CarcinomaPhase 2NCT01897610

Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC

A Phase 2 study testing Immuncell-LC in people with Advanced Hepatocellular Carcinoma, run by GC Cell Corporation at 4 sites in South Korea.

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

"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
Immuncell-LC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesSouth Korea
Study dates
Dec 2013to 4 Jul 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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have consented to the study by providing signature of self, guardian or legal representative
  • The patient is more than 20 and less than 80 years old
  • The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV
  • Child-Pugh Score should be A
  • ECOG Performance Status (ECOG-PS) is less than 2 or equal to
  • Patients who receiving or ready for Nexavar treatment
Show all 11Show fewer
  • Patients who satisfy the following conditions of the blood test and kidney function test
  • Absolute granulocyte count is bigger than 1,000/µL
  • Hemoglobin is bigger than 8.5 g/dL
  • Platelet count is bigger than 5x10^10/L
  • Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit

Who cannot join

  • Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
  • Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer.
  • Patients who had anti-cancer medication before the study with the exception of Nexavar
  • Patients who has serious dysfunction in other organs by sub-investigator's opinion
  • Patients has serious allergic-history by sub-investigator's opinion
  • Patients has serious mental disease sub-investigator's opinion
  • Pregnant women, nursing mother of having intention of being pregnant during the study
  • Patients who participated in other clinical trial within 4 weeks before this study

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Inha University Hospital

    Incheon, 400-711

  • Yonsei University Health System

    Seoul, 120-752

  • Korea University Anam Hospital

    Seoul, 136-750

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 137-701

Other trials in South Korea

About this study

Official title: Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma

"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.

Read the detailed description
  • primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group
  • secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.
Being tested
Immuncell-LC
Keywords
Immuncell-LC, advanced hepatocellular carcinoma

What participants receive

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

  • Immuncell-LCDrug

    Also called Activated T lymphocyte

    intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour

Study groups in NCT01897610
Study groupRoleWhat they receive
control groupNo interventionThe study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.
Immuncell-LC groupExperimentalThe study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after baseline by administering Nexavar chemotherapy same as control group with Immuncell-LC (10 times).
Receives: Drug: Immuncell-LC

What is being measured

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

  1. To assess progression-free survival (PFS)

    CT, PET-CT, MRI

    Measured: up to 2 years

Secondary outcomes (4)

  1. To assess the overall survival (OS)

    Measured: up to 2 years

  2. To evaluate the Disease control rate

    to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST

    Measured: up to 2 years

  3. To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date

    analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC

    Measured: up to 2 years

  4. Number of participants with adverse events

    Measured: up to 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 posted12 Jul 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJul 2017
  4. Study completion4 Jul 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897610
Sponsor's protocol ID
ILC-IIT-04
Status last verified
Jun 2023
First submitted
25 Jun 2013
Last updated
26 Jun 2023
Results posted
No
Data monitoring committee
No

Publications

  • Di Maio M, De Maio E, Perrone F, Pignata S, Daniele B. Hepatocellular carcinoma: systemic treatments. J Clin Gastroenterol. 2002 Nov-Dec;35(5 Suppl 2):S109-14. doi: 10.1097/00004836-200211002-00007.

    PubMed 12394214

  • Ganne-Carrie N, Trinchet JC. Systemic treatment of hepatocellular carcinoma. Eur J Gastroenterol Hepatol. 2004 Mar;16(3):275-81. doi: 10.1097/00042737-200403000-00005.

    PubMed 15195890

  • Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.

    PubMed 19095497

  • Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

    PubMed 18650514

  • Furuse J, Ishii H, Nakachi K, Suzuki E, Shimizu S, Nakajima K. Phase I study of sorafenib in Japanese patients with hepatocellular carcinoma. Cancer Sci. 2008 Jan;99(1):159-65. doi: 10.1111/j.1349-7006.2007.00648.x. Epub 2007 Oct 22.

    PubMed 17953709

  • Shim JH, Park JW, Choi JI, Park BJ, Kim CM. Practical efficacy of sorafenib monotherapy for advanced hepatocellular carcinoma patients in a Hepatitis B virus-endemic area. J Cancer Res Clin Oncol. 2009 Apr;135(4):617-25. doi: 10.1007/s00432-008-0496-x. Epub 2008 Oct 10.

    PubMed 18846384

  • Takayama T, Sekine T, Makuuchi M, Yamasaki S, Kosuge T, Yamamoto J, Shimada K, Sakamoto M, Hirohashi S, Ohashi Y, Kakizoe T. Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet. 2000 Sep 2;356(9232):802-7. doi: 10.1016/S0140-6736(00)02654-4.

    PubMed 11022927

  • Kim HM, Lim J, Yoon YD, Ahn JM, Kang JS, Lee K, Park SK, Jeong YJ, Kim JM, Han G, Yang KH, Kim YJ, Kim Y, Han SB. Anti-tumor activity of ex vivo expanded cytokine-induced killer cells against human hepatocellular carcinoma. Int Immunopharmacol. 2007 Dec 15;7(13):1793-801. doi: 10.1016/j.intimp.2007.08.007. Epub 2007 Aug 31.

    PubMed 17996690

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Immuncell-LC in people with Advanced Hepatocellular Carcinoma, run by GC Cell Corporation at 4 sites in South Korea.

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 11 inclusion and 8 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 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. 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?

To assess progression-free survival (PFS) (time frame: up to 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 NCT01897610, which also lists 8 linked publications.

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 26 Jun 2023.

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