{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["durvalumab","yttrium-90 radioembolization"]],"indication":"microsatellite stable colorectal cancer with liver metastases","name":"iRE-C","nct_id":"NCT04108481","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ire-c-nct04108481. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"iRE-C","arms":[{"description":"The treatment phase starts of with the immunotherapy drug (durvalumab) - \"priming doses\" every 2 weeks prior to patient getting mapped and ready for treatment with Y90-RadioEmbolization.\n\nPost-Y90-RE, treatment is approximately 2 months in combination with fixed doses (750 mg) of durvalumab. The number and timing of doses of durvalumab each patient will receive will depend on the dose level the patient is assigned to (range 2-5 doses of immunotherapy).\n\nA single patient will be treated per dose level until the first dose limiting toxicity (DLT) is recorded. Once the first DLT is recorded, two additional patients are treated at the same dose level and the trial reverts to a standard 3+3 design. Up to 6 patients will be treated at each dose level. The maximum tolerated dose (MTD) will be defined as the highest dose level for which at most 1 out of 6 patients experience a DLT.","label":"Y90-RE in combination with immunotherapy (durvalumab)","type":"EXPERIMENTAL"}],"collaborators":["Biocompatibles UK Ltd","AstraZeneca"],"completion_date":{"date":"2023-11-17","type":"ACTUAL"},"conditions":["Colorectal Cancer Metastatic","Colon Cancer","Metastatic Colorectal Cancer","Rectal Cancer","Liver Metastasis Colon Cancer","Colo-rectal Cancer","Colorectal Adenocarcinoma","Colorectal Neoplasms","Liver Metastases","Colorectal Carcinoma"],"enrollment":{"count":5,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Durvalumab","otherNames":["IMFINZI","MEDI4736","MEDI-4736","Anti-PDL1"],"type":"DRUG"},{"name":"Yttrium-90 RadioEmbolization","otherNames":["Y90-RE","Y90","Glass Microspheres","yttrium90","Y-90 Glass Microspheres"],"type":"RADIATION"}],"last_update":"2025-03-28","lead_sponsor":"University of Iowa","official_title":"Immunotherapy Combined With Yttrium-90 RadioEmbolization in the Treatment of Colorectal Cancer With Liver Metastases [iRE-C - Clinical Trial]","overall_status":"TERMINATED","phases":["PHASE1"],"primary_completion_date":{"date":"2023-11-17","type":"ACTUAL"},"primary_outcomes":[{"measure":"Determine the maximum tolerated dose (MTD) of Yttrium-90 radioembolization combined with immunotherapy durvalumab to treat liver-predominant metastatic colorectal cancer (mCRC)","timeFrame":"Initiation of treatment up to 8 weeks and 2 doses (\"priming\") of immunotherapy prior to Y90-RE."}],"references":[],"start_date":{"date":"2020-10-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer","url":"https://clinicaltrials.gov/study/NCT04108481"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ire-c-nct04108481"}