{"preliminary_commentary":{"by_channel":{"x_thread":2,"podcast":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":false},"commentary_summary":null,"drugs_tested":[["camrelizumab"]],"indication":"first-line recurrent or metastatic nasopharyngeal carcinoma","name":"CAPTAIN-1st","nct_id":"NCT03707509","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=captain-1st-nct03707509. 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":null,"arms":[{"description":"subject will receive camrelizumab 200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles","label":"Camrelizumab + Gemcitabine + Cisplatin","type":"EXPERIMENTAL"},{"description":"subject will receive placebos every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles","label":"Placebos + Gemcitabine + Cisplatin","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-12-31","type":"ESTIMATED"},"conditions":["Nasopharyngeal Carcinoma"],"enrollment":{"count":263,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Camrelizumab","otherNames":["SHR-1210"],"type":"DRUG"},{"name":"Placebos","otherNames":["Placebo - Concentrate"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":["Gemcitabine Hydrochloride for Injection"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["Cisplantin Injection"],"type":"DRUG"}],"last_update":"2022-07-01","lead_sponsor":"Jiangsu HengRui Medicine Co., Ltd.","official_title":"A Phase III, Randomized, Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of Camrelizumab+Gemcitabine+Cisplatin Versus Placebo+Gemcitabine+Cisplatin in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma","overall_status":"UNKNOWN","phases":["PHASE3"],"primary_completion_date":{"date":"2021-08-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free survival (PFS)","timeFrame":"up to 24 month"}],"references":[{"citation":"Huang Y, Sun D, Zhou H, Zhou T, Qu S, Li J, Hu C, Xu M, Li W, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Xie B, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhao S, Chen G, Zhang Y, Zhao Y, Fang W, Huang C, Li X, Hong S, Zhang L, Yang Y. Five-Year Outcome of Camrelizumab Plus Chemotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma: A Secondary Analysis of the CAPTAIN-1st Randomized Clinical Trial. JAMA Oncol. 2026 Mar 1;12(3):295-302. doi: 10.1001/jamaoncol.2025.6245.","pmid":"41609753","type":"DERIVED"},{"citation":"Xiao BJ, Sima XX, Chen G, Gulizeba H, Zhou T, Huang Y. Predictive and prognostic role of early apolipoprotein A-I alteration in recurrent or metastatic nasopharyngeal carcinoma patients treated with anti-PD-1 therapy. Cancer Med. 2023 Aug;12(16):16918-16928. doi: 10.1002/cam4.6321. Epub 2023 Jul 6.","pmid":"37409613","type":"DERIVED"},{"citation":"Yang Y, Qu S, Li J, Hu C, Xu M, Li W, Zhou T, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Zhang W, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhang B, Yang Q, Zhang X, Zou J, Fang W, Zhang L. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1162-1174. doi: 10.1016/S1470-2045(21)00302-8. Epub 2021 Jun 23.","pmid":"34174189","type":"DERIVED"}],"start_date":{"date":"2018-11-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma","url":"https://clinicaltrials.gov/study/NCT03707509"},"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/captain-1st-nct03707509"}