Hepatocellular CarcinomaNCT03790059
Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.
A study testing H101 and RFA in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- H101 and RFA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Kai Feng, M.D, +86-23-13228683383, fengkai7688@hotmail.com
Kai Feng, M.D
- Recruiting
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, 400038
Kai Feng, M.D, +86-23-13228683383, fengkai7688@hotmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- H101, RFA
- Keywords
- radiofrequency ablation, hepatocellular carcinoma, recombinant human adenovirus type 5 injection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H101Drug
Also called Recombinant Human Adenovirus Type 5 Injection（H101）.
Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.
RFAProcedure or surgery
Also called Radiofrequency ablation（RFA）.
Treat the samll HCC with the RFA.
| Study group | Role | What they receive |
|---|---|---|
| RFA combined with H101 group | Experimental | The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence. Receives: Drug: H101; Procedure: 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. Receives: Procedure: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two-years tumor-free survival.
Secondary outcomes (1)
Overall survival
The percentage of patients who receive certain treatments and are still alive after years of follow-up.
Measured: two-years overall survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study startOct 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fengkai, Southwest Hospital, China
- Investigators
- Kuansheng Ma, Ph.D, Study director, Institute of hepatobiliary surgery,Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790059
- Sponsor's protocol ID
- SWH2016LCYB-11
- Status last verified
- May 2019
- First submitted
- 23 Dec 2018
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03790059
- Acronym / sponsor ID
- SWH2016LCYB-11
- Conditions
- Hepatocellular Carcinoma
- Keywords
- radiofrequency ablation, hepatocellular carcinoma, recombinant human adenovirus type 5 injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA combined with H101 group | Experimental | Drug: H101, Procedure: RFAThe experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence. |
| Conventional RFA group | Other | Procedure: RFAThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H101Also: Recombinant Human Adenovirus Type 5 Injection（H101）.Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma. | Drug | RFA combined with H101 group |
| RFAAlso: Radiofrequency ablation（RFA）.Treat the samll HCC with the RFA. | Procedure or surgery | Conventional RFA group, RFA combined with H101 group |
Primary outcome
Tumor-free survival
Time frame: 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
1 secondary outcome
Overall survival
Time frame: two-years overall survival.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuansheng Ma, Ph.D study director
Institute of hepatobiliary surgery,Southwest Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H101 and RFA in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Feng, M.D (+86-23-13228683383, fengkai7688@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-free survival (time frame: two-years tumor-free survival.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.