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

Last updated: February 20, 2016
Sponsor: Ming Kuang
Overall Status: Active - Not Recruiting

Phase

3

Condition

Liver Cancer

Cancer/tumors

Hepatic Fibrosis

Treatment

N/A

Clinical Study ID

NCT02678013
HCC 004
  • Ages 18-75
  • All Genders

Study 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%. 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.

Eligibility Criteria

Inclusion

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 lesionand the skin as shown on ultrasound;

  6. no severe coagulation disorders (prothrombin activity＜40% or a plateletcount＜40,000/mm3);

  7. Eastern Co-operative Oncology Group performance(ECOG) status 0-1.

Exclusion

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 Awithin 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 insitu) 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 theenrolling time;

  11. Other researchers believe that the patient is not fit for inclusion.

Study Design

Total Participants: 210
Study Start date:
February 01, 2016
Estimated Completion Date:
January 31, 2022

Connect with a study center

  • Zhen-Wei Peng

    Guangzhou, Guangdong 510080
    China

    Site Not Available

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