Clinical trial NCT03790059: Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.
Official title: Radiofrequency Ablation Combined With Local Injection of Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma:A Multicenter Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: radiofrequency ablation
hepatocellular carcinoma
recombinant human adenovirus type 5 injection
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor-free survival
timeFrame: two-years tumor-free survival.
Secondary outcomes:
measure: Overall survival
timeFrame: two-years overall survival.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
Study officials:
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
name: Kuansheng Ma, Ph.D
role: STUDY_DIRECTOR
References: