Combination Therapy of Microwave Ablation and Cellular Immunotherapy for Hepatocellular Carcinoma

NCT ID: NCT02851784

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2021-03-01

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MWA only

The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used.

Group Type: ACTIVE_COMPARATOR

MWA

Intervention Type: PROCEDURE

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

MWA combined with immunotherapy

The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.

Group Type: EXPERIMENTAL

adoptive immunotherapy

Intervention Type: 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.

MWA

Intervention Type: PROCEDURE

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

Interventions

adoptive immunotherapy

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.

Intervention Type: BIOLOGICAL

MWA

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

Intervention Type: PROCEDURE

Other Intervention Names

cytokine induced kill cell

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ping Liang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ping Liang, Dr.

Role: STUDY_DIRECTOR

Chinese PLA General Hospial

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

liangping

Identifier Type: -

Identifier Source: org_study_id