Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy

Immunotherapy includes a class of medication called checkpoint inhibitors, which are a relatively new medication therapy for many types of cancer which are metastatic, meaning it has spread to other parts of the body.Immune therapy medication may be given safely with radiation treatment, and in rare cases it may even make radiotherapy more effective. When radiation therapy is given in the "palliative" setting it is given to treat pain/discomfort and not necessarily shrink or get rid of the tumour. Palliative radiotherapy may be given for many reasons, but common examples include painful bone or liver tumours, brain metastases, or symptoms from a chest tumour such as feeling breathless, cough, or bleeding. Palliative radiotherapy is usually given in smaller amounts and less frequently than other types of radiation therapy. Because checkpoint inhibitors are relatively new there is not a huge amount of evidence looking at how patients respond when the treatments are combined, or in which patients immune therapy may make radiation therapy even more effective. This study is looking at the way patients who are on or about to start immune therapy and who have been recommended for palliative radiotherapy, respond to the combination of these two treatments.

The purpose of this study is to describe the treatment outcomes in patients with cancer that has spread who are managed with a combination of immune therapy medication and radiotherapy. This research is being done because there is limited information about the outcomes of combined immune therapy and radiotherapy treatment from a patient's perspective, but also in terms of which patients may have a better response to combined treatment. In particular, the study aims to describe how combined treatment affects cancer not only in the area where radiotherapy is given, but also outside the part of the body that receives radiotherapy (which is called "abscopal" effect).

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; Immunotherapy; Radiation Therapy; Palliative
• Intervention / Treatment: Radiation: Palliative Radiation Therapy

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced malignancy referred for palliative radiotherapy for symptom control who are either (a) already on a checkpoint inhibitor or (b) about to start immunotherapy (including PD1 inhibitors, CTLA4 inhibitors or other novel checkpoint inhibitor agents)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients showing rates of grade 3 or higher toxicity	Toxicity and safety data for combined therapy with immunotherapy and palliative RT (documentation that the rates of grade 3 or higher toxicity with combined therapy is < 30%) using patient reported outcomes (symptoms, toxicities, quality of life measures), clinical outcomes (physical examination, and CT imaging results) at baseline, 1 and 3 months post radiotherapy. Only the highest toxicity/per patient will be used for analysis, regardless of the time point of when the information is collected	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-field response on imaging and evidence of out of field (abscopal) response.	Documentation of efficacy using CT imaging at 1 and 3 months post radiotherapy.	4 months
The number of ESAS questionnaires completed with the aid of a caregiver	Gather information on the efficacy collecting PRO's via in person or phone using questionnaires	1 year
biomarkers analyses as an indicator of abscopal response	Optional for consenting patients, done at 1 and 3 months post radiotherapy.	4 months
The number of EQ5D questionnaires completed with the aid of a caregive	Gather information on the efficacy collecting PRO's via in person or phone using questionnaires	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory and radiation sensitivity signatures from genotyping using archival tissue	Optional - from consenting patients (n=10) who already have readily available archival tumour tissue	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimated): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 16-6189