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Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

Primary Purpose

Liver Tumor, Evidence of Liver Transplantation

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Cryosurgery

NK immunotherapy

About this trial

This is an interventional treatment trial for Liver Tumor focused on measuring liver tumor, cryosurgery, NK immunotherapy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cancer Institute of Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cryosurgery and NK immunotherapy

Cryosurgery

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Progress free survival（PFS）

Overall survival（OS）

Full Information

NCT ID

NCT02849015

First Posted

July 21, 2016

Last Updated

September 10, 2019

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Shenzhen Hank Bioengineering Institute

1. Study Identification

Unique Protocol Identification Number

NCT02849015

Brief Title

Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

July 1, 2017 (Actual)

Study Completion Date

July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Shenzhen Hank Bioengineering Institute

4. Oversight

5. Study Description

Brief Summary

The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK) immunotherapy to tumors in transplanted liver.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Tumor, Evidence of Liver Transplantation

Keywords

liver tumor, cryosurgery, NK immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cryosurgery and NK immunotherapy

Arm Type

Experimental

Arm Description

Arm Title

Cryosurgery

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Cryosurgery

Intervention Description

Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)

Intervention Type

Biological

Intervention Name(s)

NK immunotherapy

Intervention Description

Natural killer cell(each treatment: about 10 billion cells transfusion in 3 times, i.v.)

Primary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Progress free survival（PFS）

Time Frame

1 year

Title

Overall survival（OS）

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jibing Chen, MD, PhD

Organizational Affiliation

Fuda Cancer Hospital, Guangzhou

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Institute of Fuda cancer hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510665

Country

China

12. IPD Sharing Statement

Learn more about this trial

Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

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