RFA+Highly-purified CTL vs. RFA Alone for Recurrent HCC

February 20, 2016 updated by: Ming Kuang

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Zhen-Wei Peng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age 18-75 years;
  2. recurrence of HCC 12 months after initial hepatectomy;
  3. no other treatment received except for the initial hepatectomy;
  4. single tumor≤5.0cm in diameter; or 2-3 lesions each≤3.0cm;
  5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
  6. no severe coagulation disorders (prothrombin activity<40% or a platelet count<40,000/mm3);
  7. Eastern Co-operative Oncology Group performance(ECOG) status 0-1.

Exclusion Criteria:

  1. Pregnant women, breastfeeding women or plan pregnancy for the future 2 years;
  2. The presence of vascular invasion or extrahepatic spread onimaging;
  3. Usage of strong immunosuppressive agents such as corticosteroids, cyclosporine A within six months or longer;
  4. HIV antibody or HCV 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency ablation(RFA)
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.
Procedure: RFA
Radiofrequency ablation(RFA)for small recurrent HCC
Active Comparator: RFA+CTL
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.
Procedure: RFA+highly-purified CTL
Radiofrequency ablation(RFA) plus highly-purified CTL for small recurrent HCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming Kuang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 20, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC 004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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