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Compares treatment options for Primary Liver Cancer
Official title Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer
ClinicalTrials.gov ID: NCT06766643
What this study is testing
- What it's testing
- A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join if
- Possible surgical intervention;
- Presence of other serious comorbidities, such as uncontrolled cardiovascular diseases, pulmonary diseases, or dysfunction of other organs, where the...
- 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 treatment clinical trial treatment, or having received other investigational drugs or used investigational devices...
See the full eligibility criteria
- 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 how well it works 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...
- Stable respiration for more than 10 minutes;
- Expected survival time \> 2 years.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.