Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer

NCT03008343 | Completed Phase 1

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

Brief Summary

The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus natural killer (NK) immunotherapy to recurrent liver cancer.

Conditions

Recurrent Liver Carcinoma

Keywords

Irreversible Electroporation; NK Immunotherapy; Recurrent Liver Carcinoma

Outcome Measures

Primary Outcomes (1)

• Relief degree of tumors

  It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

  3 months

Secondary Outcomes (2)

• Progress free survival（PFS）

  1 year

• Overall survival（OS）

  3 year

Study Arms (2)

Electroporation and natural killer

EXPERIMENTAL

In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Device: Irreversible Electroporation; Biological: Natural killer

Electroporation

ACTIVE COMPARATOR

In this group, the patients will receive regular irreversible electroporation (IRE) treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Device: Irreversible Electroporation

Interventions

Irreversible Electroporation DEVICE

One kind of electric ablation machine from Angiodynamic company (USA)

Also known as: IRE, NanoKnife

Electroporation; Electroporation and natural killer

Natural killer BIOLOGICAL

Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.

Also known as: HANK cell

Electroporation and natural killer

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)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Electroporation

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)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2018-12

Locations

CN (1)