{"preliminary_commentary":{"by_channel":{"bluesky_thread":2,"podcast":1,"x_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"GEMSTONE","nct_id":"NCT05587374","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gemstone-nct05587374. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"GEMSTONE","arms":[{"description":"Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \\& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Cadonilimab 10mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 14 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.","label":"Cadonilimab arm","type":"EXPERIMENTAL"},{"description":"Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \\& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.","label":"Chemoradiation arm","type":"ACTIVE_COMPARATOR"}],"collaborators":["Akeso Pharmaceuticals, Inc."],"completion_date":{"date":"2029-08-01","type":"ESTIMATED"},"conditions":["Nasopharyngeal Carcinoma","Nasopharyngeal Cancer"],"enrollment":{"count":490,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Cadonilimab","otherNames":["PD-1/CTLA-4 bi-specific antibody"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":["GEM"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["DDP"],"type":"DRUG"},{"name":"Intensity-modulated radiotherapy","otherNames":["IMRT"],"type":"RADIATION"}],"last_update":"2025-01-23","lead_sponsor":"Sun Yat-sen University","official_title":"Cadonilimab as Induction-adjuvant PD-1/CTLA-4 Bispecific Blockade Combined With Induction Chenotherapy and Concurrent Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Multicenter, Randomized, Controlled, Multicenter, Phase 3 Clinical Trial","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-08-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Failure-free survival (FFS) in intention-to-treat population","timeFrame":"3 years"},{"measure":"Overall survival (OS) in intention-to-treat population","timeFrame":"3 years"}],"references":[{"citation":"Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.","pmid":"31150573","type":"RESULT"},{"citation":"Keam SJ. Cadonilimab: First Approval. Drugs. 2022 Aug;82(12):1333-1339. doi: 10.1007/s40265-022-01761-9.","pmid":"35986837","type":"RESULT"},{"citation":"Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.","pmid":"28837405","type":"RESULT"},{"citation":"Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.","pmid":"29584545","type":"RESULT"}],"start_date":{"date":"2023-08-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Cadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE)","url":"https://clinicaltrials.gov/study/NCT05587374"},"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/gemstone-nct05587374"}