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: 
1 
Date: 
12 Feb 2022
Reviewer's report:
The reviewer thanks the authors for the response to the comments, and
understands that given that the trial is already approved by the FDA and cannot
be changed, it is moot to discuss potential changes to the protocol. Changes to
the methodology, in the opinion of this reviewer, would enhance patient safety
and increase the likelihood of the study providing stronger evidence for the value
of radioembolization in the treatment of liver malignancy. It is too late. However,
this reviewer encourages the investigators to exercise their ability to choose who
to treat and avoid giving Y90 to more than 25% of liver in ALBI 2 patients, who
are allowed for accrual according to the inclusion/exclusion criteria in Table 1.
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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?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes