Table 2.

Schedule of activites

Procedures	Screening and inclusion	Baseline6	MR-guided adaptive SBRT (Arm A only)	Week 4 post randomization	Every 4 weeks post randomization1	Every 3 months post randomization	Study termination (18 months post randomization)
Informed consent, demographic data, in-/exclusion criteria, medical history	√
Physical examination9		√	√2	√		√	√
Laboratory assessment8		√		√		√	√
Study specific blood and urine collection7		√		√		√3
Pain assessment10		√		√	√4	√5
Assessment of biliary complications11		√		√		√	√
Assessment of nutritional status12		√		√		√	√
Assessment of quality of life13		√		√		√	√
Randomization		√				√	√
Review of imaging	√					√	√
MR-guided adaptive SBRT			√
Concomitant disease	√			√		√	√
Concomitant medication	√		√	√	√	√	√
Adverse events and toxicity			√	√		√	√

¹Either during clinical visit or phone call

²Vital signs only

³Only week 24

⁴NRS

⁵NRS and Brief Pain Inventory

⁶Study specific examinations and blood withdrawal should only be performed after having obtained written informed consent from the patient and before randomization of the patient

⁷Study specific blood withdrawal for exploratory objectives will be conducted in conjunction with clinically indicated routine blood draws

⁸Routine laboratory: full blood count, differential blood count, aPTT, INR, Sodium, Potassium, Creatinine, serum urea, Bilirubin (total and conjugated), ASAT, ALAT, gGT, AP, Lipase, CRP, LDH, CA19.9, Albumin, Phosphate, Magnesium, Calcium, 25-OH-Vitamin D, HbA1c. The pregnancy test: bHCG urine dip stick (only in women of child bearing age at baseline) should be performed at baseline and the result should be known before randomization

⁹Physical examination includes: clinical investigation of skin, chest and abdomen; vital signs: blood pressure, pulse, temperature, breath rate, oxygen saturation; ECOG by physician or trained specialized nurse

¹⁰Pain assessment: Brief pain Inventory questionnaire, intensity assessed by NRS

¹¹Biliary complications: cholangitis, post-hepatic cholestasis requiring biliary stenting or PTCD

¹²Nutritional status: BMI, BIA

¹³Quality of life: EQ-5D-5L and Fact Hepatobiliary Symptom Index FHSI-8