Hepatocellular CarcinomaPhase 3NCT02678013
RFA+Highly-purified CTL vs. RFA Alone for Recurrent HCC
A Phase 3 study testing RFA and RFA+highly-purified CTL in people with Hepatocellular Carcinoma, run by Ming Kuang at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of cancer-related death worldwide. Recurrence of tumor within the liver remnant is common, with a reported 5-year recurrence rate of 70%. 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?
- RFA and RFA+highly-purified CTL
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jan 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
- age 18-75 years;
- recurrence of HCC 12 months after initial hepatectomy;
- no other treatment received except for the initial hepatectomy;
- single tumor≤5.0cm in diameter; or 2-3 lesions each≤3.0cm;
- lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
- no severe coagulation disorders (prothrombin activity<40% or a platelet count<40,000/mm3);
- Eastern Co-operative Oncology Group performance(ECOG) status 0-1.
Who cannot join
- Pregnant women, breastfeeding women or plan pregnancy for the future 2 years;
- The presence of vascular invasion or extrahepatic spread onimaging;
- Usage of strong immunosuppressive agents such as corticosteroids, cyclosporine A within six months or longer;
- HIV antibody or HCV antibody positive;
- Immunodeficiency diseases or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and type 1 diabetes);
- Suffering with cancers (except skin cancer, prostate cancer or cervical carcinoma in situ) at the enrolling time or 5 years before;
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- Suffering with other organ failure;
- Suffering with severe mental illness;
- Drug addiction (including alcohol) for 1 year before the enrolling time;
- Participate in other Clinical trials within three months prior to 3 months before the enrolling time;
- Other researchers believe that the patient is not fit for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiofrequency Ablation Combined With Highly-purified CTL vs. Radiofrequency Ablation Alone for Recurrent HCC
Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of cancer-related death worldwide. Recurrence of tumor within the liver remnant is common, with a reported 5-year recurrence rate of 70%. Repeat hepatectomy is an effective treatment for intrahepatic HCC but with a small proportion of resection rate because of the poor functional liver reserve and postoperative complications. Radiofrequency ablation(RFA) is becoming the main effective treatment for small HCC (≤5.0cm). The efficacy of RFA for recurrent HCC has been reported to be comparable to those achieved by surgery with minimal, but higher local recurrence rate after RFA. It has been reported that immunotherapy in patients who underwent curative treatment for HCC, adjuvant immunotherapy with activated CIK cells increased recurrence-free and overall survival. But there is little evidence for adjuvant immunotherapy of recurrence 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. So our hypothesis is that RFA combined with immunotherapy (Highly-purified CTL) is superior to RFA for recurrent HCC. The aim of this prospective study is to compare the outcome of RFA combined with immunotherapy (Highly-purified CTL) with RFA for small recurrent HCC after partial hepatectomy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- RFA, RFA+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.
RFAProcedure or surgery
Radiofrequency ablation(RFA)for small recurrent HCC
RFA+highly-purified CTLProcedure or surgery
Radiofrequency ablation(RFA) plus highly-purified CTL for small recurrent HCC
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation(RFA) | Experimental | RFA was performed according to the Guidelines of Radiofrequency Ablation Therapy for Liver Cancer: Chinese Expert Consensus Statement issued by the Chinese Society of Liver Cancer and Chinese Society of Clinical Oncology RFA was performed under real-time ultrasound guidance. RFA was performed by using a commercially available Cool-tipTM RFA system (Valleylab, Boulder, CO, USA), or a RF 2000 system (Radio-Therapeutics Mountain View, CA). Grounding was achieved by attaching 2 pads to the patient's back or legs. Receives: Procedure: RFA |
| RFA+CTL | Active comparator | RFA was performed the same as RFA Arm.Peripheral blood (20-30mL) for manufacturing the individualized highly-purified CTL agent was collected from the respective patients who were randomized to the immunotherapy group before starting treatment. The highly-purified CTL agent was prepared at a central manufacturing facility. Patients in the immunotherapy group received 5*10E9 of the highly-purified CTL agent intravenously over 60 minutes without any premedication and then were observed for at least 30 minutes. They were scheduled to receive highly-purified CTL: 4-6 treatments at a frequency of once two-week during 6 months after receiving RFA, followed by 6-9 treatments during 6 months to 2 years after receiving RFA. Receives: Procedure: RFA+highly-purified CTL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Measured: 2 years
Secondary outcomes (2)
Overall survival
Measured: 5 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ming Kuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Kuang, Sun Yat-sen University
- Investigators
- Ming Kuang, Ph.D., Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678013
- Sponsor's protocol ID
- HCC 004
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
PubMed 21374666Lee JH, Lee Y, Lee M, Heo MK, Song JS, Kim KH, Lee H, Yi NJ, Lee KW, Suh KS, Bae YS, Kim YJ. A phase I/IIa study of adjuvant immunotherapy with tumour antigen-pulsed dendritic cells in patients with hepatocellular carcinoma. Br J Cancer. 2015 Dec 22;113(12):1666-76. doi: 10.1038/bjc.2015.430. Epub 2015 Dec 10.
PubMed 26657650Harding JJ, El Dika I, Abou-Alfa GK. Immunotherapy in hepatocellular carcinoma: Primed to make a difference? Cancer. 2016 Feb 1;122(3):367-77. doi: 10.1002/cncr.29769. Epub 2015 Nov 5.
PubMed 26540029
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Combined With Highly-purified CTL vs. Radiofrequency Ablation Alone for Recurrent HCC
- ClinicalTrials.gov ID
- NCT02678013
- Acronym / sponsor ID
- HCC 004
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Ming KuangUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of cancer-related death worldwide. Recurrence of tumor within the liver remnant is common, with a reported 5-year recurrence rate of 70%. Repeat hepatectomy is an effective treatment for intrahepatic HCC but with a small proportion of resection rate because of the poor functional liver reserve and postoperative complications. Radiofrequency ablation(RFA) is becoming the main effective treatment for small HCC (≤5.0cm). The efficacy of RFA for recurrent HCC has been reported to be comparable to those achieved by surgery with minimal, but higher local recurrence rate after RFA. It has been reported that immunotherapy in patients who underwent curative treatment for HCC, adjuvant immunotherapy with activated CIK cells increased recurrence-free and overall survival. But there is little evidence for adjuvant immunotherapy of recurrence 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. So our hypothesis is that RFA combined with immunotherapy (Highly-purified CTL) is superior to RFA for recurrent HCC. The aim of this prospective study is to compare the outcome of RFA combined with immunotherapy (Highly-purified CTL) with RFA for small recurrent HCC after partial hepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation(RFA) | Experimental | Procedure: RFARFA was performed according to the Guidelines of Radiofrequency Ablation Therapy for Liver Cancer: Chinese Expert Consensus Statement issued by the Chinese Society of Liver Cancer and Chinese Society of Clinical Oncology RFA was performed under real-time ultrasound guidance. RFA was performed by using a commercially available Cool-tipTM RFA system (Valleylab, Boulder, CO, USA), or a RF 2000 system (Radio-Therapeutics Mountain View, CA). Grounding was achieved by attaching 2 pads to the patient's back or legs. |
| RFA+CTL | Active comparator | Procedure: RFA+highly-purified CTLRFA was performed the same as RFA Arm.Peripheral blood (20-30mL) for manufacturing the individualized highly-purified CTL agent was collected from the respective patients who were randomized to the immunotherapy group before starting treatment. The highly-purified CTL agent was prepared at a central manufacturing facility. Patients in the immunotherapy group received 5*10E9 of the highly-purified CTL agent intravenously over 60 minutes without any premedication and then were observed for at least 30 minutes. They were scheduled to receive highly-purified CTL: 4-6 treatments at a frequency of once two-week during 6 months after receiving RFA, followed by 6-9 treatments during 6 months to 2 years after receiving RFA. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-75 years;
- recurrence of HCC 12 months after initial hepatectomy;
- no other treatment received except for the initial hepatectomy;
- single tumor≤5.0cm in diameter; or 2-3 lesions each≤3.0cm;
- lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
Key exclusion criteria (11 listed)
- Pregnant women, breastfeeding women or plan pregnancy for the future 2 years;
- The presence of vascular invasion or extrahepatic spread onimaging;
- Usage of strong immunosuppressive agents such as corticosteroids, cyclosporine A within six months or longer;
- HIV antibody or HCV antibody positive;
- Immunodeficiency diseases or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and type 1 diabetes);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFARadiofrequency ablation(RFA)for small recurrent HCC | Procedure or surgery | Radiofrequency ablation(RFA) |
| RFA+highly-purified CTLRadiofrequency ablation(RFA) plus highly-purified CTL for small recurrent HCC | Procedure or surgery | RFA+CTL |
Primary outcome
Recurrence-free survival
Time frame: 2 years
2 secondary outcomes
Overall survival
Time frame: 5 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Background: PubMed 21374666Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
- Background: PubMed 26657650Lee JH, Lee Y, Lee M, Heo MK, Song JS, Kim KH, Lee H, Yi NJ, Lee KW, Suh KS, Bae YS, Kim YJ. A phase I/IIa study of adjuvant immunotherapy with tumour antigen-pulsed dendritic cells in patients with hepatocellular carcinoma. Br J Cancer. 2015 Dec 22;113(12):1666-76. doi: 10.1038/bjc.2015.430. Epub 2015 Dec 10.
- Background: PubMed 26540029Harding JJ, El Dika I, Abou-Alfa GK. Immunotherapy in hepatocellular carcinoma: Primed to make a difference? Cancer. 2016 Feb 1;122(3):367-77. doi: 10.1002/cncr.29769. Epub 2015 Nov 5.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Kuang, Ph.D. principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RFA and RFA+highly-purified CTL in people with Hepatocellular Carcinoma, run by Ming Kuang 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 7 inclusion and 11 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 23 Feb 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 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 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 NCT02678013, 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 23 Feb 2016.