Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: adoptive immunotherapy; Procedure: MWA

• 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

Arm && Interventions

Group	Intervention	Description
MWA combined with immunotherapy	MWA	The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.
MWA combined with immunotherapy	adoptive immunotherapy	The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.
MWA only	MWA	The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used.

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