Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer

January 8, 2025 updated by: Tianjin Medical University Cancer Institute and Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Song Tianqiang T Song, MD
  • Phone Number: +86 18622221077
  • Email: tjchi@hotmail.com

Study Contact Backup

  • Name: Meng Maobin M Meng, MD
  • Phone Number: +86 18526065681

Study Locations

  • China
      • Tianjin, China, 300060
        • 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
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sun Liyu L Sun, MM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Prior to implementing any trial-related procedures, written informed consent must be signed;
  2. Age ≥ 18 years and ≤ 75 years;
  3. Child-Pugh score ≤ 7;KPS score ≥ 70;
  4. The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);
  5. The tumor is located near major blood vessels/diaphragm/liver capsule/liver hilum;
  6. Surgically assessed as inoperable hepatocellular carcinoma or recurrence of primary hepatocellular carcinoma within 2 years after radical treatment;
  7. 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;
  8. No previous anti-tumor treatment;
  9. Normal liver (liver volume minus tumor volume) is sufficient;
  10. 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;
  11. Stable respiration for more than 10 minutes;
  12. Expected survival time > 2 years.

Exclusion Criteria:

  1. Possible surgical intervention;
  2. 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;
  3. Severe liver dysfunction exceeding the specific criteria defined in the trial;
  4. Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;
  5. Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
  6. 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;
  7. Previous treatment with anti-target tumor therapies;
  8. History of upper abdominal radiotherapy;
  9. Uncontrolled active comorbidities;
  10. Not meeting the expected survival prognosis or unable to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stereotactic body radiation therapy group
Procedure: Stereotactic Body Radiation Therapy (SBRT)
Stereotactic radiosurgery for liver lesions: with a total dose of 40~50Gy/3~5fraction;
Experimental: Radiofrequency ablation therapy group
Procedure: Radiofrequency ablation therapy
Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
PFS
Time Frame: Until the end of the study, about 2 years
Until the end of the study, about 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival rate
Time Frame: Until the end of the study, about 2 years
Until the end of the study, about 2 years
Local control rate
Time Frame: Until the end of the study, about 2 years
Until the end of the study, about 2 years
Intrahepatic control rate
Time Frame: Until the end of the study, about 2 years
Until the end of the study, about 2 years
Extrahepatic control rate
Time Frame: Until the end of the study, about 2 years
Until the end of the study, about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E20241490

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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