Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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.Oncolytic virus H101 is a genetically engineered adenovirus that lacks Elb 55ku protein.Some clinical trials have confirmed that H101 has selective oncolysis in a variety of solid tumors.Furthermore,research shows that the directly dissolving tumor activity of H101 enhanced obviously and activate the body's anti-tumor immune to induce the distal antitumor effect under the condition of mild high temperature (40 ℃ and 42 ℃).The transition zone of RFA can provide the appropriate mild high temperature.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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RFA combined with H101 group

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

Group Type EXPERIMENTAL

H101

Intervention Type DRUG

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

RFA

Intervention Type PROCEDURE

Treat the samll HCC with the RFA.

Conventional RFA group

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.

Group Type OTHER

RFA

Intervention Type PROCEDURE

Treat the samll HCC with the RFA.

Interventions

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H101

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

Intervention Type DRUG

RFA

Treat the samll HCC with the RFA.

Intervention Type PROCEDURE

Other Intervention Names

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Recombinant Human Adenovirus Type 5 Injection（H101）. Radiofrequency ablation（RFA）.

Eligibility Criteria

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Inclusion Criteria

1. The patients understand the content and significance of the study and we obtain a written informed consent from them.
2. The patients' gender are not limited and are between the ages of 18 and 75.
3. 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%.
4. The ECOG score is 0.
5. The diagnosis was a single hepatocellular carcinoma with a diameter of no more than 3cm.
6. There were no other related diseases affecting RFA treatment.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No