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Completed

NCT Number: NCT02851784

Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in hepatocellular carcinoma(HCC).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

HCC (D ≤5 cm, fewer than three tumors) patients were treated with radical MWA and 4-6 courses of immunotherapy with CIK every year. The immunotherapy were started at 2 weeks, 4 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks and then every 12 weeks after MWA. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were injected into the abdominal cavity. CIK was infused intravenously. The safety, survival effect and peripheral T-lymphocyte subsets of combination therapy group will be recorded and compared with those of MWA group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • single HCC of 5 cm or smaller;
  • three or fewer multiple HCC with a maximum dimension of 3 cm or less;
  • absence of portal vein thrombosis or extrahepatic metastases;
  • Child-Pugh classification A or B;
  • tumor accessible via a percutaneous approach. white blood cell count >2 x 109/L, platelet count >40 x 109/L,serum creatinine <110 μmol/L, aspartate aminotransferase <3 times the upper limit, serum bilirubin <2.5 times the upper limit, prothrombin time <19 seconds.

Exclusion criteria

  • pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
  • active uncontrolled infection; concurrent systemic corticosteroid treatment;
  • systemic autoimmune disease;
  • clinically significant ischemic heart disease or cardiac failure;
  • and chemotherapy or radiotherapy within the preceding 6 months

Treatment and study plan

adoptive immunotherapy

Biological

HCC (D ≤5 cm, fewer than three tumors) patients were treated with radical MWA and 4-6 courses of immunotherapy with CIK every year.The immunotherapy were started at 2 weeks, 4 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks and then every 12 weeks after MWA. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were injected into the abdominal cavity. CIK was infused intravenously.

Other names: cytokine induced kill cell

MWA

Procedure

ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up

Primary outcomes

  1. Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test.

    Time frame: up to 8 years

Secondary outcomes

  1. disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test

    Time frame: up to 8 years

Other outcomes

  1. Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test

    Time frame: up to 8 years

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Combination Therapy of Microwave Ablation and Expanding Activated Autologous Lymphocytes for Hepatocellular Carcinoma

Important dates

Study start
2009
Primary completion
2020
Study completion
2021
First posted
Aug 2, 2016
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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