NCT03790059

Brief Summary

The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the transitional area.Some clinical trials have confirmed that H101(recombinant human adenovirus type 5 injection) has selective oncolysis in a variety of solid tumors.However, there are no reports that H101 which is injected during surgery can improve the efficacy of RFA in liver cancer at present.Therefore,We used a multicenter prospective randomized controlled study as the main method to prospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined with H101 injection in reducing the postoperative recurrence rate of small hepatocellular carcinoma, and to provide a reliable evidence-based medical basis for the selection of treatment methods for small hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

October 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 16, 2019

Status Verified

May 1, 2019

Enrollment Period

3.9 years

First QC Date

December 23, 2018

Last Update Submit

October 15, 2019

Conditions

Hepatocellular Carcinoma

Keywords

radiofrequency ablationhepatocellular carcinomarecombinant human adenovirus type 5 injection

Outcome Measures

Primary Outcomes (1)

  • Tumor-free survival

    Postoperative tumor-free survival is an evaluation of tumor recurrence and metastasis.It's also an evaluation of the efficacy of the experimental group

    two-years tumor-free survival.

Secondary Outcomes (1)

  • Overall survival

    two-years overall survival.

Study Arms (2)

RFA combined with H101 group

EXPERIMENTAL

The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.

Drug: H101Procedure: RFA

Conventional RFA group

OTHER

The standard control group was the conventional RFA.Using RFA for the treatment of small HCC.The efficacy was compared with that of the experimental group combined with H101.

Procedure: RFA

Interventions

H101DRUG

Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.

Also known as: Recombinant Human Adenovirus Type 5 Injection（H101）.
RFA combined with H101 group
RFAPROCEDURE

Treat the samll HCC with the RFA.

Also known as: Radiofrequency ablation（RFA）.
Conventional RFA groupRFA combined with H101 group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients understand the content and significance of the study and we obtain a written informed consent from them.
  • The patients' gender are not limited and are between the ages of 18 and 75.
  • Liver function of Child-Pugh Class A or B;The retention rate of indocyanine green for 15 minutes is less than or equal to 20%.
  • The ECOG score is 0.
  • The diagnosis was a single hepatocellular carcinoma with a diameter of no more than 3cm.
  • There were no other related diseases affecting RFA treatment.

You may not qualify if:

  • There are tumor emboli in the large vessels of the liver;distant metastasis of HCC.
  • The patient has or has had a history of refractory ascites,hepatic encephalopathy, or esophageal varices hemorrhage.
  • The patient was complicated with other malignant tumors.
  • The patient has severe cardiac, renal and other organ dysfunction.
  • In addition to viral hepatitis, there are other active infectious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, 400038, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Kuansheng Ma, Ph.D

    Institute of hepatobiliary surgery,Southwest Hospital

    STUDY DIRECTOR

Central Study Contacts

Kai Feng, M.D

CONTACT

+86-23-13228683383fengkai7688@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2018

First Posted

December 31, 2018

Study Start

October 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

October 16, 2019

Record last verified: 2019-05

Locations

CN(2)