{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T08:35:05Z","timestamp":1793435705993,"version":"4.5.0"},"reference-count":31,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials"],"published-print":{"date-parts":[[2026,11]]},"DOI":"10.1016\/j.cct.2026.108473","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T23:46:51Z","timestamp":1789688811000},"page":"108473","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Sample size estimation for a flexible phase II oncology trial design using two dependent endpoints with nested response metrics"],"prefix":"10.1016","volume":"170","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5304-0530","authenticated-orcid":false,"given":"Jiangtao","family":"Gou","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2736-2303","authenticated-orcid":false,"given":"Fengqing","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cct.2026.108473_b1","series-title":"Multiple endpoints in clinical trials guidance for industry","author":"FDA","year":"2022"},{"issue":"5","key":"10.1016\/j.cct.2026.108473_b2","doi-asserted-by":"crossref","first-page":"596","DOI":"10.1080\/10543406.2022.2162066","article-title":"On dependence assumption in p-value based multiple test procedures","volume":"33","author":"Gou","year":"2023","journal-title":"J. Biopharm. Statist."},{"issue":"2","key":"10.1016\/j.cct.2026.108473_b3","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1016\/j.ejca.2008.10.026","article-title":"New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)","volume":"45","author":"Eisenhauer","year":"2009","journal-title":"Eur. J. Cancer"},{"issue":"4","key":"10.1016\/j.cct.2026.108473_b4","doi-asserted-by":"crossref","first-page":"248","DOI":"10.1038\/sj.thj.6200301","article-title":"Phase II study of cyclophosphamide, interferon-alpha and betamethasone (CIB) as induction therapy for patients 60\u201375 years of age with multiple myeloma stages II and III","volume":"4","author":"Lundin","year":"2003","journal-title":"Hematol. J."},{"key":"10.1016\/j.cct.2026.108473_b5","series-title":"Clinical Trials in Oncology","author":"Green","year":"2012"},{"issue":"14","key":"10.1016\/j.cct.2026.108473_b6","doi-asserted-by":"crossref","first-page":"2269","DOI":"10.1080\/10428194.2023.2262066","article-title":"Comparative effectiveness between mosunetuzumab monotherapy clinical trial and real-world data in relapsed\/refractory follicular lymphoma in third or subsequent lines of systemic therapy","volume":"64","author":"McGough","year":"2023","journal-title":"Leuk. Lymphoma"},{"issue":"1","key":"10.1016\/j.cct.2026.108473_b7","doi-asserted-by":"crossref","DOI":"10.1136\/jitc-2019-000347","article-title":"Phase 2 study of pembrolizumab in patients with advanced rare cancers","volume":"8","author":"Naing","year":"2020","journal-title":"J. ImmunoTherapy Cancer"},{"key":"10.1016\/j.cct.2026.108473_b8","series-title":"Minimal residual disease and complete response in multiple myeloma: Use as endpoints to support accelerated approval: Draft guidance for industry","author":"FDA","year":"2026"},{"issue":"10192","key":"10.1016\/j.cct.2026.108473_b9","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/S0140-6736(19)31240-1","article-title":"Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (cassiopeia): a randomised, open-label, phase 3 study","volume":"394","author":"Moreau","year":"2019","journal-title":"Lancet"},{"issue":"3","key":"10.1016\/j.cct.2026.108473_b10","doi-asserted-by":"crossref","DOI":"10.1002\/cam4.7006","article-title":"Efficacy and safety of camrelizumab combined with oxaliplatin and S-1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single-arm study","volume":"13","author":"Zhong","year":"2024","journal-title":"Cancer Med."},{"issue":"12","key":"10.1016\/j.cct.2026.108473_b11","doi-asserted-by":"crossref","DOI":"10.1111\/cns.70659","article-title":"Phase 2 trial of PD-1 inhibitor sintilimab in recurrent\/progressive meningioma","volume":"31","author":"Wang","year":"2025","journal-title":"CNS Neurosci. Ther."},{"key":"10.1016\/j.cct.2026.108473_b12","series-title":"Statistical Methods for Rates and Proportions","author":"Fleiss","year":"2003"},{"key":"10.1016\/j.cct.2026.108473_b13","series-title":"Elements of Distribution Theory","author":"Severini","year":"2005"},{"issue":"28","key":"10.1016\/j.cct.2026.108473_b14","doi-asserted-by":"crossref","first-page":"5229","DOI":"10.1002\/sim.9909","article-title":"Sample size optimization for clinical trials using graphical approaches for multiplicity adjustment","volume":"42","author":"Zhang","year":"2023","journal-title":"Stat. Med."},{"issue":"2","key":"10.1016\/j.cct.2026.108473_b15","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1002\/bimj.202000081","article-title":"Sample size optimization and initial allocation of the significance levels in group sequential trials with multiple endpoints","volume":"64","author":"Gou","year":"2022","journal-title":"Biom. J."},{"key":"10.1016\/j.cct.2026.108473_b16","series-title":"Multiple Comparison Procedures","author":"Hochberg","year":"1987"},{"key":"10.1016\/j.cct.2026.108473_b17","series-title":"Handbook of Multiple Comparisons","first-page":"11","article-title":"Multiple test procedures based on p-values","author":"Tamhane","year":"2022"},{"issue":"4","key":"10.1016\/j.cct.2026.108473_b18","doi-asserted-by":"crossref","first-page":"800","DOI":"10.1093\/biomet\/75.4.800","article-title":"A sharper Bonferroni procedure for multiple tests of significance","volume":"75","author":"Hochberg","year":"1988","journal-title":"Biometrika"},{"issue":"2","key":"10.1016\/j.cct.2026.108473_b19","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1093\/biomet\/asn018","article-title":"On weighted hochberg procedures","volume":"95","author":"Tamhane","year":"2008","journal-title":"Biometrika"},{"issue":"1","key":"10.1016\/j.cct.2026.108473_b20","first-page":"339","article-title":"Hochberg procedure under negative dependence","volume":"28","author":"Gou","year":"2018","journal-title":"Statist. Sinica"},{"issue":"1","key":"10.1016\/j.cct.2026.108473_b21","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1080\/19466315.2025.2518056","article-title":"Improved trimmed weighted hochberg procedures with two endpoints and sample size optimization","volume":"18","author":"Gou","year":"2026","journal-title":"Stat. Biopharm. Res."},{"key":"10.1016\/j.cct.2026.108473_b22","first-page":"65","article-title":"A simple sequentially rejective multiple test procedure","volume":"6","author":"Holm","year":"1979","journal-title":"Scand. J. Stat."},{"issue":"4","key":"10.1016\/j.cct.2026.108473_b23","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1002\/sim.3495","article-title":"A graphical approach to sequentially rejective multiple test procedures","volume":"28","author":"Bretz","year":"2009","journal-title":"Stat. Med."},{"issue":"5","key":"10.1016\/j.cct.2026.108473_b24","doi-asserted-by":"crossref","first-page":"739","DOI":"10.1002\/sim.3513","article-title":"A recycling framework for the construction of Bonferroni-Based multiple tests","volume":"28","author":"Burman","year":"2009","journal-title":"Stat. Med."},{"key":"10.1016\/j.cct.2026.108473_b25","doi-asserted-by":"crossref","first-page":"655","DOI":"10.1093\/biomet\/63.3.655","article-title":"On closed testing procedures with special reference to ordered analysis of variance","volume":"63","author":"Marcus","year":"1976","journal-title":"Biometrika"},{"issue":"3","key":"10.1016\/j.cct.2026.108473_b26","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1002\/pst.301","article-title":"Power and sample size when multiple endpoints are considered","volume":"6","author":"Senn","year":"2007","journal-title":"Pharm. Stat."},{"issue":"4","key":"10.1016\/j.cct.2026.108473_b27","doi-asserted-by":"crossref","first-page":"899","DOI":"10.1093\/biomet\/asu032","article-title":"A class of improved hybrid hochberg\u2013hommel type step-up multiple test procedures","volume":"101","author":"Gou","year":"2014","journal-title":"Biometrika"},{"issue":"6","key":"10.1016\/j.cct.2026.108473_b28","doi-asserted-by":"crossref","first-page":"829","DOI":"10.1093\/neuonc\/not330","article-title":"Historical benchmarks for medical therapy trials in surgery- and radiation-refractory meningioma: a RANO review","volume":"16","author":"Kaley","year":"2014","journal-title":"Neuro-Oncol."},{"issue":"3","key":"10.1016\/j.cct.2026.108473_b29","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1002\/pst.291","article-title":"Gatekeeping procedures with clinical trial applications","volume":"6","author":"Dmitrienko","year":"2007","journal-title":"Pharm. Stat."},{"key":"10.1016\/j.cct.2026.108473_b30","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1016\/j.conctc.2015.08.002","article-title":"A two-stage design with two co-primary endpoints","volume":"1","author":"Song","year":"2015","journal-title":"Contemp. Clin. Trials Commun."},{"key":"10.1016\/j.cct.2026.108473_b31","first-page":"253","article-title":"Two-stage design sample size determination for two doses in oncology phase II trials","volume":"3","author":"Xiang","year":"2025","journal-title":"New Engl. J. Stat. Data Sci."}],"container-title":["Contemporary Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714426002594?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1551714426002594?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T08:16:31Z","timestamp":1793434591000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1551714426002594"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,11]]},"references-count":31,"alternative-id":["S1551714426002594"],"URL":"https:\/\/doi.org\/10.1016\/j.cct.2026.108473","relation":{},"ISSN":["1551-7144"],"issn-type":[{"value":"1551-7144","type":"print"}],"subject":[],"published":{"date-parts":[[2026,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Sample size estimation for a flexible phase II oncology trial design using two dependent endpoints with nested response metrics","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cct.2026.108473","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"108473"}}