Phase III multi-centre open-label randomized controlled trial of selective internal radiation therapy (SIRT) versus Sorafenib in locally advanced hepatocellular carcinoma(SIRveNIB)
- VernacularTitle:Элэгний хэсэг газрын хожуу үеийн хорт хавдрын үед сонгомол дотуур туяа эмчилгээ ба сорафениб эмчилгээг хийж харьцуулсан олон төвт эмнэлзүйн III үеийн судалгааны үр дүнгээс
- Author:
Ariunaa Kh
;
Sanduijav R
;
Bolormaa Ya
;
Tuyatsetseg A
- Publication Type:Journal Article
- Keywords:
SIRT-Selective Internal Radiation Therapy;
CT-computed tomography;
ECOG-Eastern Cooperative Oncology Group;
ALT-alanine aminotransferase;
AST-aspartate aminotransferase;
AFP-serum alpha-feto protein;
CR-Complete Response;
PR-Partial Response
- From:Mongolian Medical Sciences
2016;177(3):20-24
- CountryMongolia
- Language:Mongolian
-
Abstract:
Background
This study is a multi-centre, open-label, randomised controlled trial that will compare the impact of
selective internal radiation therapy (SIRT) using SIR-Spheres® yttrium-90 microspheres versus sorafenib
on overall survival in patients with locally advanced hepatocellular carcinoma (HCC). A definitive RCT
comparing the 2 most promising therapies in locally-advanced HCC will impact on outcomes in a large
number of patients and change clinical practice. This will also pave the way for future trials in combined
modality therapies in HCC.
Methods
The study is structured so that patients with locally advanced HCC, who satisfy the study eligibility
criteria, will be randomised to receive either: Treatment Arm A: Oral Sorafenib therapy at a dose of 400
mg b.i.d until disease progression, no further response, complete regression or unacceptable toxicity or
Treatment Arm B: A single administration of SIR-Spheres into the liver targeted at HCC in the liver by
the trans-arterial route.
Results
Twenty patients treated with 90Y-RE and nineteen patients received Sorafenib at our institution from 14
March 2011, and 30 June 2016 were included. Data from 39 consecutive patients were analyzed. The
majority of patients were Child Pugh class B(90%), Barcelona Clinic liver Cancer(BCLC) stage C(58.5%)
and Okuda class I (89.5%). Approximately 71% patients diagnosed in IIIa stage and 70% of patients had
HBV infection. In the analysis for best response, three of 20 patients in the SIRT group (15%) achieved
a partial response 7 of 19 patients (46%) had stable disease, whereas in Sorafenib group, two of 19
patients in the SIRT group (12%) achieved a partial response 9 of 19 patients (39%) had stable disease.
Conclusion
This study shows the potential efficacy of SIR-Spheres and sorafenib. In summary, selective internal
radiation therapy (SIRT) using SIR-Spheres is a promising treatment for well selected patients with
unresectable HCC. Sorafenib is effective for the patients with locally advanced HCC without portal vein
thrombosis (PVT).
- Full text:P020170420814371341808.pdf
