NCT02851784

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

10.7 years

First QC Date

July 25, 2016

Last Update Submit

March 2, 2021

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomaablationimmunotherapycytokine induced kill cell

Outcome Measures

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.

    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

    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

    up to 8 years

Study Arms (2)

MWA only

ACTIVE COMPARATOR

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

Procedure: MWA

MWA combined with immunotherapy

EXPERIMENTAL

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

Biological: adoptive immunotherapyProcedure: MWA

Interventions

adoptive immunotherapyBIOLOGICAL

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.

Also known as: cytokine induced kill cell
MWA combined with immunotherapy
MWAPROCEDURE

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

MWA combined with immunotherapyMWA only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Ping Liang, Dr.

    Chinese PLA General Hospial

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 2, 2016

Study Start

December 1, 2009

Primary Completion

July 30, 2020

Study Completion

March 1, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

CN(1)