Hepatocellular CarcinomaNCT04520906
To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
A study testing microwave ablation in people with Hepatocellular Carcinoma, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 13 sites in China.
Trial summary
Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer. 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?
- microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 13 sitesChina
- Study dates
- 17 Dec 2020to 1 Apr 2023
- 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
- Pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma).
- Single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm.
- No invasion of blood vessels, gallbladder, adjacent organs and distant metastasis.
- Child-Pugh class A or B classification, or meet the standard after treatment.
- Able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent.
Who cannot join
- Pregnant or breastfeeding, or preparing to become pregnant during the trial.
- Participating in clinical trials of other devices or drugs.
- Uncorrectable coagulation dysfunction (after corrective treatment, the PT exceeds the normal control value by more than 3s).
- PLT <50x109/L.
- Intractable massive ascites.
- Cachexia.
Show all 10Show fewer
- MRI examination is contraindicated or the investigator judges it is not suitable for MRI examination.
- Patients with bleeding from esophageal (fundus of stomach) varicose veins 1 month before surgery.
- Patients with impaired consciousness or unable to cooperate with treatment.
- The investigator judged that it is not suitable to participate in clinical trials.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shandong Provincial Hospital
Jinan, Shandong, 250021
The Central Hospital of Lishui City
Lishui, Zhejiang, 323000
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200120
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: Prospective, Multicenter, Single-group Target Study to Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.
Read the detailed description
The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- microwave ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave ablationDevice
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Subjects will be treated with microwave ablation. Receives: Device: microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete tumor ablation rate
the percentage of complete ablation subjects for all subjects undergoing ablation surgery.
Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation.
Measured: 1 month after surgery
Secondary outcomes (2)
First complete tumor ablation rate
the percentage of subjects who did not undergo the second one month after the operation accounted for all the ablation trials.
Measured: 1 month after surgery
Complete ablation rate of lesions
the percentage of lesions that are completely ablated to all lesions undergoing ablation.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start17 Dec 2020
- Primary completion6 Apr 2022
- Study completion1 Apr 2023
Why it stopped: Obtaining medical device market approval through the predicate device comparison route.
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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, multi-center, single-group target value
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaojun Teng, Doctor, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520906
- Sponsor's protocol ID
- MWA1.0
- Status last verified
- Jun 2025
- First submitted
- 18 Aug 2020
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-group Target Study to Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT04520906
- Acronym / sponsor ID
- MWA1.0
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Obtaining medical device market approval through the predicate device comparison route.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTDIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 20 Aug 2020 (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.
Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.
Detailed description
The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multi-center, single-group target value
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Device: microwave ablationSubjects will be treated with microwave ablation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma).
- Single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm.
- No invasion of blood vessels, gallbladder, adjacent organs and distant metastasis.
- Child-Pugh class A or B classification, or meet the standard after treatment.
- Able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding, or preparing to become pregnant during the trial.
- Participating in clinical trials of other devices or drugs.
- Uncorrectable coagulation dysfunction (after corrective treatment, the PT exceeds the normal control value by more than 3s).
- PLT <50x109/L.
- Intractable massive ascites.
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 |
|---|---|---|
| microwave ablationultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients | Device | single-arm |
Primary outcome
Complete tumor ablation rate
Time frame: 1 month after surgery
the percentage of complete ablation subjects for all subjects undergoing ablation surgery. Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation.
2 secondary outcomes
First complete tumor ablation rate
Time frame: 1 month after surgery
Complete ablation rate of lesions
Time frame: 1 month after surgery
Results and safety
The study was stopped early (reason given: Obtaining medical device market approval through the predicate device comparison route.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Gaojun Teng, Doctor principal investigator
Zhongda Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microwave ablation in people with Hepatocellular Carcinoma, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 13 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study was stopped early (reason given: Obtaining medical device market approval through the predicate device comparison route.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete tumor ablation rate (time frame: 1 month after surgery). 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 1 Jul 2025.