{"preliminary_commentary":{"by_channel":{"x_thread":14,"youtube":3,"podcast":2,"x_video":1},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05302284\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"RC48-C016","nct_id":"NCT05302284","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rc48-c016-nct05302284. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive RC48-ADC + JS001 every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).","label":"RC48-ADC + JS001","type":"EXPERIMENTAL"},{"description":"Participants will receive Gemcitabine + cisplatin or carboplatin every 3 weeks (Q3W) for maximum 6 weeks or until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).","label":"Gemcitabine + cisplatin/carboplatin","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-04-30","type":"ESTIMATED"},"conditions":["Urothelial Carcinoma","HER2-expressing"],"enrollment":{"count":452,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"RC48-ADC","otherNames":["Disitamab Vedotin"],"type":"DRUG"},{"name":"Toripalimab","otherNames":["JS001"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"}],"last_update":"2023-12-18","lead_sponsor":"RemeGen Co., Ltd.","official_title":"A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-free survival (PFS), evaluated by independent review committee","timeFrame":"Up to approximately 3 years"},{"measure":"Overall survival (OS)","timeFrame":"Up to approximately 3 years"}],"references":[{"citation":"Sheng X, Zeng G, Zhang C, Zhang Q, Bian J, Niu H, Li J, Shi Y, Yao K, Hu B, Liu Z, Liao H, Yu Z, Jin B, Zhao P, Yang T, Liu X, Qin Y, Xue X, Gou X, Huang J, Gu J, Qi X, Zhang L, Ma G, Liu B, Fang J, Jiang S, He Z, Zhou A, Guo J; RC48-C016 Trial Investigators. Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer. N Engl J Med. 2025 Dec 11;393(23):2324-2337. doi: 10.1056/NEJMoa2511648. Epub 2025 Oct 19.","pmid":"41124210","type":"DERIVED"}],"start_date":{"date":"2022-06-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma","url":"https://clinicaltrials.gov/study/NCT05302284"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/rc48-c016-nct05302284"}