Comparing two treatments for inoperable primary liver cancer

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

This study is testing which treatment works better for people with inoperable primary liver cancer by comparing stereotactic radiosurgery and radiofrequency ablation.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (other)
• Locations: 1 site (Tianjin)
• Trial ID: NCT06766643 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial is designed to evaluate the efficacy and safety of stereotactic radiosurgery versus radiofrequency ablation in patients with inoperable primary liver cancer. The study will enroll patients who have tumors located near critical structures and are not candidates for surgery. Participants will be randomly assigned to receive either stereotactic radiotherapy or radiofrequency ablation, with the aim of determining which treatment is more effective. A total of 130 patients will be recruited for this trial, with 65 in each treatment group.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of hepatocellular carcinoma that is deemed inoperable.

Not a fit: Patients with tumors that are operable or those who have received prior anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with inoperable primary liver cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison is novel.

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.

Where this trial is running

Tianjin

• 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 (RECRUITING)

Study contacts

• Study coordinator: Song Tianqiang T Song, MD

Conditions: Primary Liver Cancer, Primary liver cancer，Stereotactic body radiation therapy，Radiofrequency ablation therapy