Stereotactic Radiosurgery Versus Radiofrequency Ablation for Primary Liver Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SBRT)

    Procedure/Surgery

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

  • Radiofrequency ablation therapy

    Procedure/Surgery

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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Stereotactic body radiation therapy groupExperimental treatment 1 intervention
Group B: Radiofrequency ablation therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Time frame
Until the end of the study, about 2 years

Secondary outcomes

1

Overall survival rate

Time frame
Until the end of the study, about 2 years
2

Local control rate

Time frame
Until the end of the study, about 2 years
3

Intrahepatic control rate

Time frame
Until the end of the study, about 2 years
4

Extrahepatic control rate

Time frame
Until the end of the study, about 2 years

Other outcomes

Sponsors and contacts

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