Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

September 10, 2019 updated by: Fuda Cancer Hospital, Guangzhou
The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK) immunotherapy to tumors in transplanted liver.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

By enrolling patients with tumors in transplanted liver adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and NK cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510665
        • Cancer institute of Fuda cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  • Body tumor 1-6, the maximum tumor length < 5 cm
  • KPS ≥ 70, lifespan > 6 months
  • Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cryosurgery and NK immunotherapy
In this group, the patients will receive liver cryosurgery first to destroy big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Device: Cryosurgery
Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
Biological: NK immunotherapy
Natural killer cell(each treatment: about 10 billion cells transfusion in 3 times, i.v.)
ACTIVE_COMPARATOR: Cryosurgery
In this group, the patients will receive liver cryosurgery to destroy big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Device: Cryosurgery
Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progress free survival（PFS）
Time Frame: 1 year
1 year
Overall survival（OS）
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Shenzhen Hank Bioengineering Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (ESTIMATE)

July 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-liverTx

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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