Review for 10.1186/s12876-022-02204-1 (2022)

Reviewer’s report
Title: 
A prospective, multicenter, open-label, single-arm clinical trial design to
evaluate the safety and efficacy of 90Y resin microspheres for the treatment of
unresectable HCC: the DOORwaY90 (Duration Of Objective Response with
arterial Ytrrium-90) study
Version: 
0 
Date: 
24 Dec 2021
Reviewer's report:
SUMMARY
The submitted manuscript is a study protocol of a prospective, multicenter, open-
label, single-arm non comparative clinical trial.
The aim of the trial is to evaluate the safety and efficacy of 90Y resin
microspheres for the treatment of unresectable hepatocellular carcinoma as a first
line treatment using a personalized dosimetry approach.
MAJOR STRENGHTS
1. The exposed clinical study protocol refers to what should be considered a
pivotal trial regarding radioembolization using resin microsphere for the
treatment of unresectable HCC.
2. The clinical trial has already been approved by institutional and local ethic
committees of participating centers and is currently open for recruitment.
3. Very clear, well organized and well written manuscript.
4. All aspects of the trial are well described.
MAJOR WEAKNESSES
1. No major weakness regarding the manuscript.
ADVANCES IN KNOWLEDGE / IMPLICATIONS FOR PATIENT CARE
The present manuscript clearly describes the study protocol of the DOORwaY90
study.
This trial is of major interest seen the valuable data it will provide regarding
safety and efficacy of Ytrrium-90 resin microsphere in the setting of
unresectable HCC.
Particularly, primary endpoints of the study (overall response rate and duration
of response) and dosimetric data could help refining the role of
radioembolization in the context of unresectable HCC. 
SPECIFIC COMMENTS
No specific comments
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Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
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Is the use of statistics and treatment of uncertainties appropriate?
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from apparent manipulation?
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