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Hepatocellular CarcinomaPhase 3NCT02709070

Resection+Highly Purified CTL Versus Resection Alone for HCC

A Phase 3 study testing resection and highly-purified CTL in people with Hepatocellular Carcinoma, run by Sun Yat-sen University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

There is little evidence showed that adjuvant therapy had been shown to extend the survival of patients with hepatocellular carcinoma (HCC) receiving surgical resection. We investigated whether injections of highly-purified Cytotoxic T lymphocytes prolongs recurrence-free survival of patients after resection for 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?
resection and highly-purified CTL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
Mar 2016to Mar 2022
Phase
Phase 3
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

  • 1. Age 18-75 years; 2. First diagnosed HCC, no other treatment received; 3.Child-pugh A-B 4. No severe coagulation disorders (prothrombin activity<40% or a platelet count<40,000/mm3); 5. Eastern Co-operative Oncology Group performance(ECOG) status 0-1.

Who cannot join

  • 1. Pregnant women, breastfeeding women or plan pregnancy for the future 2 years; 2. The presence of vascular invasion or extrahepatic spread on imaging; 3. Usage of strong immunosuppressive agents such as corticosteroids, cyclosporine A within six months or longer; 4. HIV antibody or hepatitis C virus antibody positive; 5. Immunodeficiency diseases or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and type 1 diabetes); 6. Suffering with cancers (except skin cancer, prostate cancer or cervical carcinoma in situ) at the enrolling time or 5 years before; 7. Suffering with other organ failure; 8. Suffering with severe mental illness; 9. Drug addiction (including alcohol) for 1 year before the enrolling time; 10. Participate in other Clinical trials within three months prior to 3 months before the enrolling time; 11. Other researchers believe that the patient is not fit for inclusion.

About this study

Official title: Resection Combined With Highly-purified CTL Versus Resection Alone for HCC

There is little evidence showed that adjuvant therapy had been shown to extend the survival of patients with hepatocellular carcinoma (HCC) receiving surgical resection. We investigated whether injections of highly-purified Cytotoxic T lymphocytes prolongs recurrence-free survival of patients after resection for HCC.

Read the detailed description

Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of cancer-related death worldwide. Resection is considered as the main curative treatment for HCC, but recurrence of tumor within the liver remnant is common, with a reported 5-year recurrence rate of 70%, which results in poor prognosis of HCC, and the high recurrence rate has led efforts to develop adjuvant therapies to reduce recurrence. However, the benefit of any form of adjuvant therapy remains unclear. Current guidelines didn't recommend any adjuvant therapy after resection. A previous clinical trial from Japan reported that cytokine-induced killer(CIK) cell immunotherapy increased recurrence-free survival (RFS) after surgical resection of HCC. Immunotherapy has become an optional treatment for HCC. Cytotoxic T lymphocytes(CTL), a kind of effective T cells that specific recognizing and killing antigen targeted cells through cloning amplification after receiving antigen information from antigen presented cell and playing key role to clear cancerous cells. There is little evidence for adjuvant CTL treatment for HCC receiving resection. So our hypothesis is that adjuvant highly-purified CTL is superior to resection alone for HCC. The aim of this prospective study is to compare the outcome of resection combined with highly-purified CTL with resection for HCC.

Being tested
resection, highly-purified CTL
Keywords
highly-purified CTL
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • resectionProcedure or surgery

    hepatectomy for HCC

  • highly-purified CTLProcedure or surgery

    hepatectomy first, followed by highly-purified CTL treatment

Study groups in NCT02709070
Study groupRoleWhat they receive
resectionActive comparatorResection was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant and the possibility of a negative resection margin. The investigators performed anatomical resection aiming at a resection margin of at least 1 cm. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 minutes and 5 minutes, respectively. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.
Receives: Procedure: resection
highly-purified CTLExperimentalPeripheral blood (20-30mL) for manufacturing the individualized highly-purified CTL agent was collected from the respective participants who were randomized to the immunotherapy group before starting treatment. The highly-purified CTL agent was prepared at a central manufacturing facility. Participants in the immunotherapy group received a number up to 5×10E9 of the highly-purified CTL agent intravenously over 60 minutes without any premedication and then were observed for at least 30 minutes. Participants were scheduled to receive highly-purified CTL: 4-6 treatments at a frequency of once two-week during 6 months after receiving resection, followed by 6-9 treatments during 6 months to 2 years after receiving resection.
Receives: Procedure: resection; Procedure: highly-purified CTL

What is being measured

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

  1. recurrence free survival

    from the date of randomization to the first recurrence or to death from any cause

    Measured: 2-year

Secondary outcomes (1)

  1. overall survival

    from the date of randomization until death from any cause, and cancer-specific survival was measured from the date.

    from the date of randomization until death from any cause, and cancer-specific survival was measured from the date of randomization until death resulting from HCC

    Measured: 5-year

Timeline

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

  1. First posted15 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2020 (estimated)
  4. Study completionMar 2022 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02709070
Sponsor's protocol ID
HCC 005
Status last verified
Mar 2016
First submitted
10 Mar 2016
Last updated
16 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.

    PubMed 25747273

  • Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.

    PubMed 23269991

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing resection and highly-purified CTL in people with Hepatocellular Carcinoma, run by Sun Yat-sen University.

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 1 inclusion and 1 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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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 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?

Results are not available in the source record.

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: 2-year). 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 NCT02709070, which also lists 3 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 16 Mar 2016.

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