Primary Liver CancerPhase 2NCT06766643
Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and Radiofrequency ablation therapy in people with Primary Liver Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) and Radiofrequency ablation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Jan 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Prior to implementing any trial-related procedures, written informed consent must be signed;
- Age ≥ 18 years and ≤ 75 years;
- Child-Pugh score ≤ 7;KPS score ≥ 70;
- The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);
- The tumor is located near major blood vessels/diaphragm/liver capsule/liver hilum;
- Surgically assessed as inoperable hepatocellular carcinoma or recurrence of primary hepatocellular carcinoma within 2 years after radical treatment;
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- According to the criteria for evaluating the efficacy of solid tumors, there should be at least one measurable lesion by imaging, with the lesion size not exceeding 5 cm; total number of lesions ≤ 3;
- No previous anti-tumor treatment;
- Normal liver (liver volume minus tumor volume) is sufficient;
- Normal major organ functions, including blood routine tests [absolute neutrophil count (ANC) ≥ 1.5 × 10^9, platelets ≥ 70 × 10^9, hemoglobin ≥ 80 g/L], liver function tests [bilirubin < 3.0 mg/dL, international normalized ratio (INR) < 1.7, albumin ≥ 2.8 g/dL, aspartate transaminase (AST)/alanine transaminase (ALT) < 6], serum creatinine < 1.5 times the upper limit of normal, or creatinine clearance ≥ 60 mL/min;
- Stable respiration for more than 10 minutes;
- Expected survival time > 2 years.
Who cannot join
- Possible surgical intervention;
- Presence of other serious comorbidities, such as uncontrolled cardiovascular diseases, pulmonary diseases, or dysfunction of other organs, where the overall health status is poor and may result in treatment intolerance;
- Severe liver dysfunction exceeding the specific criteria defined in the trial;
- Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;
- Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
- Currently participating in an interventional clinical trial treatment, or having received other investigational drugs or used investigational devices within 4 weeks before the first treatment;
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- Previous treatment with anti-target tumor therapies;
- History of upper abdominal radiotherapy;
- Uncontrolled active comorbidities;
- Not meeting the expected survival prognosis or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meng Maobin M Meng, MD contact
China1 site, 1 recruiting
- Recruiting
Department of Hepatobiliary Oncology and Radiation Oncology,Tianjin Medical University Cancer Institute & Hospital,Key Laboratory of Cancer Prevention and Therapy,National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer
Tianjin, 300060
Song Tianqiang T Song, MD, +86 18622221077, tjchi@hotmail.com
Meng Maobin M, MD, +86 18526065681, mmeng@tmu.edu.cn
About this study
Official title: A Prospective, Randomized, Controlled Phase II Clinical Trial of Stereotactic Radiosurgery Versus Radiofrequency Ablation in Primary Liver Cancer in a Special Site of Surgical Evaluation for Non-operable
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
Read the detailed description
This study is a prospective, randomized, controlled Phase II clinical trial aimed at recruiting patients with primary liver cancer who are deemed inoperable after surgical evaluation, with tumor lesions located near major blood vessels, the diaphragm, the liver capsule, or the porta hepatis. The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy and radiofrequency ablation as treatment options for such patients. It must be determined by the investigator whether stereotactic radiotherapy or radiofrequency ablation is the preferred treatment for these patients. Eligible patients will be randomly assigned in a 1:1 ratio to one of the following treatment groups: stereotactic radiotherapy or radiofrequency ablation. The study is expected to enroll 65 patients in each group.
- Conditions
- Primary Liver Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Radiofrequency ablation therapy
- Keywords
- Primary liver cancer，Stereotactic body radiation therapy，Radiofrequency ablation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Procedure or surgery
Stereotactic radiosurgery for liver lesions: with a total dose of 40~50Gy/3~5fraction;
Radiofrequency ablation therapyProcedure or surgery
Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy group | Experimental | Not described Receives: Procedure: Stereotactic Body Radiation Therapy (SBRT) |
| Radiofrequency ablation therapy group | Experimental | Not described Receives: Procedure: Radiofrequency ablation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: Until the end of the study, about 2 years
Secondary outcomes (4)
Overall survival rate
Measured: Until the end of the study, about 2 years
Local control rate
Measured: Until the end of the study, about 2 years
Intrahepatic control rate
Measured: Until the end of the study, about 2 years
Extrahepatic control rate
Measured: Until the end of the study, about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766643
- Sponsor's protocol ID
- E20241490
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Phase II Clinical Trial of Stereotactic Radiosurgery Versus Radiofrequency Ablation in Primary Liver Cancer in a Special Site of Surgical Evaluation for Non-operable
- ClinicalTrials.gov ID
- NCT06766643
- Acronym / sponsor ID
- E20241490
- Conditions
- Primary Liver Cancer
- Keywords
- Primary liver cancer，Stereotactic body radiation therapy，Radiofrequency ablation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jan 2025 (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.
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
Detailed description
This study is a prospective, randomized, controlled Phase II clinical trial aimed at recruiting patients with primary liver cancer who are deemed inoperable after surgical evaluation, with tumor lesions located near major blood vessels, the diaphragm, the liver capsule, or the porta hepatis. The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy and radiofrequency ablation as treatment options for such patients. It must be determined by the investigator whether stereotactic radiotherapy or radiofrequency ablation is the preferred treatment for these patients. Eligible patients will be randomly assigned in a 1:1 ratio to one of the following treatment groups: stereotactic radiotherapy or radiofrequency ablation. The study is expected to enroll 65 patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy group | Experimental | Procedure: Stereotactic Body Radiation Therapy (SBRT) |
| Radiofrequency ablation therapy group | Experimental | Procedure: Radiofrequency ablation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Prior to implementing any trial-related procedures, written informed consent must be signed;
- Age ≥ 18 years and ≤ 75 years;
- Child-Pugh score ≤ 7;KPS score ≥ 70;
- The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);
- The tumor is located near major blood vessels/diaphragm/liver capsule/liver hilum;
Key exclusion criteria (10 listed)
- Possible surgical intervention;
- Presence of other serious comorbidities, such as uncontrolled cardiovascular diseases, pulmonary diseases, or dysfunction of other organs, where the overall health status is poor and may result in treatment intolerance;
- Severe liver dysfunction exceeding the specific criteria defined in the trial;
- Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;
- Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Stereotactic radiosurgery for liver lesions: with a total dose of 40~50Gy/3~5fraction; | Procedure or surgery | Stereotactic body radiation therapy group |
| Radiofrequency ablation therapyRadiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions | Procedure or surgery | Radiofrequency ablation therapy group |
Primary outcome
PFS
Time frame: Until the end of the study, about 2 years
4 secondary outcomes
Overall survival rate
Time frame: Until the end of the study, about 2 years
Local control rate
Time frame: Until the end of the study, about 2 years
Intrahepatic control rate
Time frame: Until the end of the study, about 2 years
Extrahepatic control rate
Time frame: Until the end of the study, about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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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.
Meng Maobin M Meng, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) and Radiofrequency ablation therapy in people with Primary Liver Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 12 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Tianqiang T Song, MD (+86 18622221077, tjchi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Until the end of the study, about 2 years). 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 9 Jan 2025.