Y-90 SIRT for Unresectable HCC Larger Than 7cm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed or clinically diagnosed HCC
Unresectable HCC as assessed by a team of surgeons
The largest tumor size > 7 cm
Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
Disqualifiers
Macrovascular invasion or extrahepatic metastasis
Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
Organ (heart and kidneys) dysfunction
History of other malignancies
Trial design
Design model
Single group
Treatments tested in this trial
SIRT
Procedure/SurgeryThe patients will receive 1-2 sessions of SIRT.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: SIRTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) per mRECIST
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST
Time frame
3 yearsSecondary outcomes
1
Objective response rate (ORR) per RECIST 1.1
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Time frame
3 years2
Disease control rate (DCR)
The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
Time frame
3 years3
Progression free survival (PFS)
The time from date of treatment initiation until the first occurrence of disease progression (according to mRECIST and RECIST 1.1) or death due to any cause, whichever occurs first.
Time frame
3 years4
time to response (TTR)
The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1)
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov