Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT02984566
Eligibility Criteria:
Inclusion Criteria:
* ECOG performance status 0-1
* Life expectancy \>6 months
* Number of lesions: ≤ 3
* Lesion size : \< 10 cm for a single lesion (and up to 10 cm cumulative diameter for multiple lesions)
* Child-Pugh A or B7 within 6 weeks prior to study entry
* Unsuitable for RFA or resection or transplant
* Distance from GTV to luminal structures (i.e., oesophagus, stomach, duodenum, small or large bowel) ≥ 10mm
* All blood work obtained within 6 weeks prior to study entry with adequate organ function
* May have had previous surgery, RFA or ethanol injection
* Patient must have been discussed at multidisciplinary tumour board with consensus opinion for SBRT
Exclusion Criteria:
* HCC/cholangiocarcinoma with evidence of metastatic disease including nodal or distant metastases
* Metastatic disease with complete liver disease response to first-line chemotherapy (i.e. no target for SBRT)
* Previous radiation to the liver (including SIRTEX)
* Untreated HIV or active hepatitis B/C
* On systemic antineoplastic drug therapy within 7 days before inclusion
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02984566
Study Brief:
Protocol Section:
NCT02984566