Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

NCT02849015 | Completed Phase 1

• 1 other identifier: NK-liverTx
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Tumor; Evidence of Liver Transplantation

Keywords

liver tumor; cryosurgery; NK immunotherapy

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (2)

• Progress free survival（PFS）

  1 year

• Overall survival（OS）

  3 years

Study Arms (2)

Cryosurgery and NK immunotherapy

EXPERIMENTAL

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; Biological: NK immunotherapy

Cryosurgery

ACTIVE COMPARATOR

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

Interventions

Cryosurgery DEVICE

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

Cryosurgery; Cryosurgery and NK immunotherapy

NK immunotherapy BIOLOGICAL

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

Cryosurgery and NK immunotherapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Shenzhen Hank Bioengineering Institute: collaborator

Study Sites (1)

Cancer Institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jibing Chen, MD, PhD

  Fuda Cancer Hospital, Guangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 29, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: September 12, 2019

Record last verified: 2018-07

Locations

CN (1)