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CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorBeijing 302 Hospital

About this trial

The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology

Unfeasible or refusing to undergo other treatments;

Residual normal liver volume ≥700 cc;

With decompensated cirrhosis (Child-Pugh B or C classification);

Disqualifiers

With Tumor thrombus；

With extrahepatic metastasis;

With lymph node involvement.

Trial population

The small HCC patients with decompensated cirrhosis who refused or were ineligible for other treatments.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cyberknife stereotactic body radiation therapy

    Radiation

    A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Overall survival time

OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.

Time frame
From date of randomization until the date of death from any cause, assessed up to 36 months
2

Progression-free survival time

PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.

Time frame
From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
3

Local control time

LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary outcomes

1

Radiation-induced liver injury rates

Time frame
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
2

Adverse reaction

Time frame
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing 302 Hospital

Lead sponsor

Source ClinicalTrials.gov
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