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

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: H101; Procedure: RFA

• Registration Number: NCT03790059
• Lead Sponsor: Southwest Hospital, China

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2018-12-23
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-16
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA combined with H101 group	H101	The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.
RFA combined with H101 group	RFA	The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.
Conventional RFA group	RFA	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.

Primary Outcome Measures

Name	Time	Method
Tumor-free survival	two-years 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

Secondary Outcome Measures

Name	Time	Method
Overall survival	two-years overall survival.	The percentage of patients who receive certain treatments and are still alive after years of follow-up.

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,Southwest Hospital; 🇨🇳 Chongqing, China