Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer

NCT06766643 | Recruiting Phase 2

• 1 other identifier: E20241490
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites

Conditions

Primary Liver Cancer

Keywords

Primary liver cancer，Stereotactic body radiation therapy，Radiofrequency ablation therapy

Outcome Measures

Primary Outcomes (1)

• PFS

  Until the end of the study, about 2 years

Secondary Outcomes (4)

• Overall survival rate

  Until the end of the study, about 2 years

• Local control rate

  Until the end of the study, about 2 years

• Intrahepatic control rate

  Until the end of the study, about 2 years

• Extrahepatic control rate

  Until the end of the study, about 2 years

Study Arms (2)

Stereotactic body radiation therapy group

EXPERIMENTAL

Procedure: Stereotactic Body Radiation Therapy (SBRT)

Radiofrequency ablation therapy group

EXPERIMENTAL

Procedure: Radiofrequency ablation therapy

Interventions

Stereotactic Body Radiation Therapy (SBRT) PROCEDURE

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

Stereotactic body radiation therapy group

Radiofrequency ablation therapy PROCEDURE

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

Radiofrequency ablation therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

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, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Song Tianqiang T Song, MD

CONTACT

+86 18622221077; tjchi@hotmail.com

Meng Maobin M Meng, MD

CONTACT

+86 18526065681

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 9, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-12

Locations

CN (1)