Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer

NCT ID: NCT06766643

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Primary Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic body radiation therapy group

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: PROCEDURE

Stereotactic radiosurgery for liver lesions: with a total dose of 40\~50Gy/3\~5fraction;

Radiofrequency ablation therapy group

Group Type: EXPERIMENTAL

Radiofrequency ablation therapy

Intervention Type: PROCEDURE

Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Stereotactic radiosurgery for liver lesions: with a total dose of 40\~50Gy/3\~5fraction;

Intervention Type: PROCEDURE

Radiofrequency ablation therapy

Radiofrequency ablation therapy:1 complete radiofrequency ablation of liver lesions for liver lesions

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Song Tianqiang T Song, MD

Role: CONTACT

tjchi@hotmail.com

+86 18622221077

Meng Maobin M Meng, MD

Role: CONTACT

+86 18526065681

Facility Contacts

Song Tianqiang T Song, MD

Role: primary

tjchi@hotmail.com

+86 18622221077

Meng Maobin M, MD

Role: backup

mmeng@tmu.edu.cn

+86 18526065681

Other Identifiers

E20241490

Identifier Type: -

Identifier Source: org_study_id