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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT03042156
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18 years or older
2. Histologically or cytologically confirmed solid tumor malignancy
3. Advanced disease (locally advanced and/or metastatic)
4. Life expectancy \> 3 months
5. Patients planned to receive palliative radiotherapy (including whole liver radiotherapy)
6. Patients who are already on or about to commence a checkpoint inhibitor
7. Measurable disease according to irRECIST on CT or MRI
8. ECOG performance status 0-2
9. Able to provide informed consent
10. Able to complete telephone/email communication
11. Additional criteria for subset of patients for abscopal analysis (to be done post hoc):
1. Measurable disease outside irradiated volume
2. Must be on same checkpoint inhibitor/immunotherapy (or same class of checkpoint inhibitor) for 3 months prior to radiotherapy and have stable disease or oligoprogression in past 3 months
3. Availability of prior biopsy specimen (preferably fresh frozen tissue) for research and genotyping
Exclusion Criteria:
1. Medical conditions which may be contraindications to radiotherapy
2. Any medical or non-medical issue that would affect the patient's ability to provide informed consent for study participation, or would interfere with the patient's treatment on study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03042156
Study Brief:
Protocol Section:
NCT03042156