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
Qualifiers
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
Treatments tested in this trial
- Hepatopulmonary radio-sterilization
Treatment groups
44 Participants
are divided into 2 treatment groupsLocations
1Sheba Medical Center52621, Ramat Gan Israel
Sponsors and collaborators
Sheba Medical Center
Lead sponsor
Source ClinicalTrials.gov