Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT02851784
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Primary Completion: 2020-07-30
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. single HCC of 5 cm or smaller;
2. three or fewer multiple HCC with a maximum dimension of 3 cm or less;
3. absence of portal vein thrombosis or extrahepatic metastases;
4. Child-Pugh classification A or B;
5. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	up to 8 years

Secondary Outcome Measures

Name	Time	Method
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	up to 8 years

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China