Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder

NCT02332551 | Completed DMC

• 1 other identifier: JF-20141229
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress Free Survival (PFS) will be recorded.

Conditions

Hepatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.

  30 days (+/- 3 days) post treatment

Secondary Outcomes (1)

• Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

  Immediately post treatment to 2 years post treatment

Other Outcomes (1)

• Progress free survival(PFS)

  24months

Study Arms (2)

NanoKnife IRE System

EXPERIMENTAL

90 pulses of 70 microseconds each in duration will be administered per electrode pair

Device: NanoKnife

Control

NO INTERVENTION

Interventions

NanoKnife DEVICE

Irreversible electroporation (IRE) is a new, minima-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and the gallbladder .

Also known as: IRE

NanoKnife IRE System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
• Tumor from gallbladder is \<0.5 cm
• not suitable for surgical resection or transplantation,
• have at least one, but less than or equal to 3 tumors,
• of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter,
• Child-Pugh class A,B
• Eastern Cooperative Oncology Group (ECOG) score of 0-1,
• American Society of Anaesthesiologists (ASA) score ≤ 3,
• a prothrombin time ratio \> 50%,
• platelet count \> 80x109/L,
• ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
• are able to comprehend and willing to sign the written informed consent form (ICF),
• have a life expectancy of at least 3 months.

You may not qualify if:

• eligible for surgical treatment or transplantation for HCC,
• Hepatic carcinoma developed on an already transplanted liver,
• cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
• any active implanted device (eg Pacemaker),
• women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
• have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

中国

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Lizhi l Niu, PHD

  FUDA Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2019-04

Locations

CN (1)