Combination of Cryosurgery and NK Immunotherapy for Advanced Kidney Cancer

Sponsor

Fuda Cancer Hospital, Guangzhou (Other)

Overall Status

Completed

CT.gov ID

NCT02843607

Collaborator

Shenzhen Hank Bioengineering Institute (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced kidney cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Cancer	Device: Cryosurgery Biological: NK immunotherapy	Phase 1/Phase 2

Detailed Description

By enrolling patients with kidney cancer 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 nature killer (NK) cells for advanced kidney cancer.

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cryosurgery and NK immunotherapy In this group, the patients will receive comprehensive cryosurgery first to destroy all 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, 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 comprehensive cryosurgery to destroy all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).	Device: Cryosurgery Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)

Arm

Intervention/Treatment

Experimental: Cryosurgery and NK immunotherapy

In this group, the patients will receive comprehensive cryosurgery first to destroy all 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, 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 comprehensive cryosurgery to destroy all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).

Device: Cryosurgery

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

Outcome Measures

Primary Outcome Measures

Relief degree [3 months]
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

Progress free survival（PFS） [1 year]
Overall survival（OS） [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute in Fuda cancer hospital	Guangzhou	Guangdong	China	510665

Sponsors and Collaborators

Fuda Cancer Hospital, Guangzhou
Shenzhen Hank Bioengineering Institute

Investigators

Principal Investigator: Guifeng Liu, PhD, Fuda Cancer Hospital, Guangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fuda Cancer Hospital, Guangzhou

ClinicalTrials.gov Identifier:

NCT02843607

Other Study ID Numbers:

NK-kidney

First Posted:

Jul 26, 2016

Last Update Posted:

Sep 12, 2019

Last Verified:

Jul 1, 2019

Keywords provided by Fuda Cancer Hospital, Guangzhou

Kidney Cancer

Cryosurgery

NK Immunotherapy

Additional relevant MeSH terms:

Carcinoma, Renal Cell

Study Results

No Results Posted as of Sep 12, 2019