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

Table 2 DOORwaY90 trial assessment schedule

Evaluations	Baseline¹	SIRT treatment	Re-treatment²	1 month (± 2 weeks)	Follow-up visits 2, 4, 6, 9 and 12 months (± 2 weeks) post-index procedure	2 years (± 1 month) clinic/phone
Patient informed consent	X
Inclusion/exclusion assessment	X
Physical exam including vital signs	X				X
Demographics and medical history	X
Pregnancy test	X
Child–Pugh assessment	X		X
Laboratory tests³	X	X	X	X	X
^99mTc-MAA lung shunt scan and liver SPECT/CT	X
Imaging (CT or MRI) of chest, abdomen, and pelvis	X				X⁴
Hepatic angiography	X	X	X
Treatment plan assessment	X
ECOG performance test	X
Medication assessment	X	X	X		X⁵
Tumor response (mRECIST)⁶	X				X
CBCT (or in-room fan-beam CT)	X	X	X
⁹⁰Y resin microsphere treatment		X	X
Post-treatment imaging of abdomen with ⁹⁰Y SPECT/CT or ⁹⁰Y PET/CT		X	X
Adverse event assessment	X	X	X	X	X	X
Quality of life questionnaires (EQ-5D-5L, FACT-Hep)		X⁷			X

¹Performed within 28 days prior to SIRT treatment procedure
²SIRT re-treatment may occur at the discretion of the treating physician within 4 weeks of index procedure
³CBC/Diff, biochemistry, total protein, AST, ALT, ALP, bilirubin, albumin, creatinine, prothrombin time, partial thromboplastin time, international normalized ratio. Hepatitis B and C, and serology at baseline visit only
⁴Modality of imaging (CT or MRI) must match method used at baseline
⁵Information on all concomitant medications collected for first 2 months; after 2 months, only oncologic and/or liver specific medications
⁶Images sent to core laboratory for analysis
⁷Completed pre-procedure

ISSN: 1471-230X