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
Qualifiers
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
Treatments tested in this trial
- SIRT
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov