Hepatopulmonary Radio-sterilization With Immunotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheba Medical Center
About this trial
In this protocol the investigators aim to overcome hepatic-pulmonary metastases-induced resistance to immunotherapy through high dose radiation therapy (SBRT) targeted to the metastases themselves, aiming, when possible, to ablate all macroscopic disease in these organs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically- or cytologically-confirmed diagnosis of colorectal cancer (CRC).
Metastatic or recurrent CRC, deemed surgically or medically unresectable.
Subjects who are candidates to receive immunotherapy, whether MSS or MSI-high.
Subjects who have liver and / or lung metastases amenable to SBRT.
Disqualifiers
Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 3 weeks of the first dose of treatment.
Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Has had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Hepatopulmonary radio-sterilization
RadiationHepatopulmonary radio-sterilization - ablation of hepatic and pulmonary metastases
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: MSI-H mCRCExperimental treatment 1 intervention
Group B: MSS mCRC.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety and tolerability
Time frame
2 yearsSecondary outcomes
1
6 month PFS
progression free survival at 6 months
Time frame
6 months2
Overall survival (OS)
Overall survival (OS)
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: