NCT04309747

Brief Summary

This is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 10, 2020

Last Update Submit

March 15, 2020

Conditions

Liver Cancer

Keywords

nanosecond knifeliver cancer

Outcome Measures

Primary Outcomes (1)

  • Effectiveness analysis

    The effective rate of nanosecond knife ablation for liver cancer

    12 months

Secondary Outcomes (10)

  • Secondary validity analysis

    12 months

  • Secondary validity analysis

    12 months

  • Secondary validity analysis

    12 months

  • Secondary validity analysis

    12 months

  • Secondary validity analysis

    12 months

  • +5 more secondary outcomes

Study Arms (1)

nanosecond knife group

EXPERIMENTAL

This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

Procedure: nanosecond knife liver cancer ablation

Interventions

nanosecond knife liver cancer ablationPROCEDURE

This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

nanosecond knife group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
  • Age: 18-75 years old, regardless of gender.
  • Liver function: Child-Pugh A or B, or Child C will reach B.
  • No serious heart, lung, brain and other organ dysfunction. Normal or nearly normal blood coagulation function. Prothrombin time does not exceed 50% of the normal control, and platelets are more than 50 × 109 / L.
  • It is usually suitable for single tumor with a maximum diameter of ≤5cm, or the number of tumors of ≤3 and a maximum diameter of ≤3cm.
  • For single tumors \> 5 cm in diameter that cannot be surgically removed, or multiple tumors with a maximum diameter \> 3 cm, local ablation can be used as p palliative comprehensive treatment.
  • According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
  • Patients signed informed consent to participate in the trial.

You may not qualify if:

  • The lesion of liver cancer is huge or diffuse ;
  • Merged portal vein to secondary branch tumor thrombus or hepatic vein tumor thrombus, invasion of nearby organs or distant metastasis;
  • tumors located on the surface of the liver, of which more than 1/3 tumor size are bare;
  • liver function: Child-pugh C, those could not improve after liver protective treatment;
  • Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment;
  • Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding;
  • Refractory large amount of ascites and cachexia;
  • active infection, especially inflammation of the biliary system;
  • Severe failure of major organs such as liver, kidney, heart, lung and brain;
  • Patients with unconsciousness or unable to cooperate with treatment;
  • Subjects could not be followed up and fell off;
  • Those who discontinued treatment, or the case records were incomplete for various reasons, and were determined by researchers to be unable to be evaluated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.

    PMID: 18477802BACKGROUND

  • Gu YK, Luo RG, Huang JH, Si Tu QJ, Li XX, Gao F. Transarterial embolization ablation of hepatocellular carcinoma with a lipiodol-ethanol mixture. World J Gastroenterol. 2010 Dec 7;16(45):5766-72. doi: 10.3748/wjg.v16.i45.5766.

    PMID: 21128329BACKGROUND

  • Bargellini I, Vignali C, Cioni R, Petruzzi P, Cicorelli A, Campani D, De Simone P, Filipponi F, Bartolozzi C. Hepatocellular carcinoma: CT for tumor response after transarterial chemoembolization in patients exceeding Milan criteria--selection parameter for liver transplantation. Radiology. 2010 Apr;255(1):289-300. doi: 10.1148/radiol.09090927.

    PMID: 20308465BACKGROUND

  • Fruhling P, Nilsson A, Duraj F, Haglund U, Noren A. Single-center nonrandomized clinical trial to assess the safety and efficacy of irreversible electroporation (IRE) ablation of liver tumors in humans: Short to mid-term results. Eur J Surg Oncol. 2017 Apr;43(4):751-757. doi: 10.1016/j.ejso.2016.12.004. Epub 2017 Jan 11.

    PMID: 28109674BACKGROUND

  • Distelmaier M, Barabasch A, Heil P, Kraemer NA, Isfort P, Keil S, Kuhl CK, Bruners P. Midterm Safety and Efficacy of Irreversible Electroporation of Malignant Liver Tumors Located Close to Major Portal or Hepatic Veins. Radiology. 2017 Dec;285(3):1023-1031. doi: 10.1148/radiol.2017161561. Epub 2017 Aug 11.

    PMID: 28799842BACKGROUND

  • Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.

    PMID: 11592607BACKGROUND

  • Liu J, Fang C, Jin X, Tian G, Sun Z, Hong L, Pan J, Chen X, Zhao J, Cao H, Jiang T. Nanosecond pulsed electric field ablation-induced modulation of sphingolipid metabolism is associated with Ly6c2+ mononuclear phagocyte differentiation in liver cancer. Mol Oncol. 2023 Jun;17(6):1093-1111. doi: 10.1002/1878-0261.13372. Epub 2023 Jan 21.

    PMID: 36587393DERIVED

  • Xu M, Xu D, Dong G, Ren Z, Zhang W, Aji T, Zhao Q, Chen X, Jiang T. The Safety and Efficacy of Nanosecond Pulsed Electric Field in Patients With Hepatocellular Carcinoma: A Prospective Phase 1 Clinical Study Protocol. Front Oncol. 2022 Jul 13;12:869316. doi: 10.3389/fonc.2022.869316. eCollection 2022.

    PMID: 35912221DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Central Study Contacts

Tian'an Jiang, PhD

CONTACT

18857127666tiananjiang@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: To evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 16, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

Shared Documents
STUDY PROTOCOL