{"entity":{"id":"nct05359393","kind":"trial","name":"A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis","aka":["Miracle-1"],"tldr":"A phase 2 trial in colorectal cancer, run by Fudan University, not yet recruiting.","summary":"A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis is a phase 2, interventional study registered as NCT05359393 by Fudan University, with a registry enrolment figure of 52 participants, started 2022-12-01 and due to reach its primary completion in 2027-09-01. Interventions recorded: a combination therapy including tislelizumab. Conditions listed: Advanced Rectal Cancer; Liver Metastasis; Pulmonary Metastasis; Microsatellite Stable Colorectal Carcinoma. Primary outcome: NED rate. Colorectal eligibility wording from the registry: \"* Initial colonoscopy and pathology: adenocarcinoma;\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05359393","url":"https://clinicaltrials.gov/study/NCT05359393"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05359393","phase":"2","setting":"Radiotherapy Followed by Chemotherapy and Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Liver/ Pulmonary Metastasis(Miracle-1): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial","sponsor":"Fudan University","participation":[{"nct":"NCT05359393","source":"https://clinicaltrials.gov/study/NCT05359393","fetchedAt":"2026-10-07T16:53:40.482Z","studySha256":"2f1132f4c0e5d8a3a57c3024fa36ed257eca0e916d727b02c3f636afbe514a78","overallStatus":"NOT_YET_RECRUITING","lastUpdatePosted":"2022-11-14","leadSponsor":"Fudan University","collaboratorCount":0,"minimumAge":"18 Years","maximumAge":"75 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":52,"enrolmentType":"ESTIMATED","siteCount":1,"recruitingSiteCount":0,"countries":["China"]}],"started":"2022-12-01","startedType":"estimated","enrolled":52,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05359393/","neighbours":{"cancer":[{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}