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Comparison of Efficacy in SBRT of Large HCC With or Without TACE

ConditionsLarge HCC PatientsStereotactic Body Radiation TherapyTranscatheter Arterial Chemoembolization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorBeijing 302 Hospital

About this trial

The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.

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

single lesion and longest tumor diameter were 5-10cm;

CP-A or B classification;

Eastern Cooperative Oncology Group (ECOG) score 0-1;

Disqualifiers

tumor thrombus;

lymph node involvement;

extrahepatic metastasis.

Trial population

The large HCC patients who receive SBRT with or without TACE.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: CK-SBRT with TACE group
Group B: CK-SBRT group

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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