Nctid:
NCT06225921
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000002294", "term"=>"Carcinoma, Squamous Cell"}, {"id"=>"D000077277", "term"=>"Esophageal Squamous Cell Carcinoma"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000018307", "term"=>"Neoplasms, Squamous Cell"}, {"id"=>"D000004938", "term"=>"Esophageal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000006258", "term"=>"Head and Neck Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000004935", "term"=>"Esophageal Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M5550", "name"=>"Carcinoma, Squamous Cell", "asFound"=>"Squamous Cell Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M1733", "name"=>"Esophageal Squamous Cell Carcinoma", "asFound"=>"Esophageal Squamous Cell Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M20451", "name"=>"Neoplasms, Squamous Cell", "relevance"=>"LOW"}, {"id"=>"M8088", "name"=>"Esophageal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M9348", "name"=>"Head and Neck Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M8085", "name"=>"Esophageal Diseases", "relevance"=>"LOW"}, {"id"=>"T2141", "name"=>"Esophageal Cancer", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M2853", "name"=>"Immunomodulating Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>6}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-29", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2025-01-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-04", "studyFirstSubmitDate"=>"2024-01-12", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-06", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Safety of combination adebrelimab and dalpiciclib as assessed by number of participants who experience adverse events", "timeFrame"=>"up to 15 weeks", "description"=>"Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)."}, {"measure"=>"Feasibility of combination adebrelimab and dalpiciclib as assessed by number of participants who experience adverse events", "timeFrame"=>"up to 15 weeks", "description"=>"Patients proceed to surgery without experiencing prolonged treatment-related delays. An extended treatment-related delay will be considered if it exceeds 37 days from the initially scheduled surgery date. In terms of feasibility, if there is any treatment toxicity of any grade that could adversely impact prognosis, as judged by the investigators, the planned operative date should be re-evaluated."}], "secondaryOutcomes"=>[{"measure"=>"Maximum Tolerated Dose (MTD) of dalpiciclib as determined by number of participants with dose limiting toxicities (DLT)", "timeFrame"=>"up to 15 weeks", "description"=>"Maximum tolerated dose will be determined by the maximum dose at which the least number of participants experience dose-limiting toxicity. The dose limiting toxicity is defined using the Common Terminology Criteria for Adverse Events (CTCAE)."}, {"measure"=>"Major Pathologic Response", "timeFrame"=>"up to 15 weeks", "description"=>"Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells."}, {"measure"=>"Objective response rate (ORR)", "timeFrame"=>"up to 15 weeks", "description"=>"Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of Adebrelimab and Dalpiciclib"}, {"measure"=>"Progression free survival(PFS)", "timeFrame"=>"Up to 2 years", "description"=>"Proportion of participants who achieve progression free survival post treatment"}, {"measure"=>"Overall survival (OS)", "timeFrame"=>"Up to 2 years", "description"=>"Proportion of participants who achieve survival post treatment"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Esophageal Squamous Cell Carcinoma", "Neoadjuvant therapy", "Immunotherapy", "CDK4/6 inhibitor"], "conditions"=>["Esophageal Squamous Cell Carcinoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"30089078", "type"=>"BACKGROUND", "citation"=>"Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8."}, {"pmid"=>"36633525", "type"=>"BACKGROUND", "citation"=>"Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763."}, {"pmid"=>"34160577", "type"=>"BACKGROUND", "citation"=>"Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. doi: 10.1001/jamasurg.2021.2373. Erratum In: JAMA Surg. 2022 Sep 1;157(9):859. doi: 10.1001/jamasurg.2022.3765."}, {"pmid"=>"36400384", "type"=>"BACKGROUND", "citation"=>"Tang H, Wang H, Fang Y, Zhu JY, Yin J, Shen YX, Zeng ZC, Jiang DX, Hou YY, Du M, Lian CH, Zhao Q, Jiang HJ, Gong L, Li ZG, Liu J, Xie DY, Li WF, Chen C, Zheng B, Chen KN, Dai L, Liao YD, Li K, Li HC, Zhao NQ, Tan LJ. Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy for locally advanced esophageal squamous cell carcinoma: a prospective multicenter randomized clinical trial. Ann Oncol. 2023 Feb;34(2):163-172. doi: 10.1016/j.annonc.2022.10.508. Epub 2022 Nov 15."}, {"pmid"=>"26254683", "type"=>"BACKGROUND", "citation"=>"Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5."}, {"pmid"=>"35108470", "type"=>"BACKGROUND", "citation"=>"Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A, El Hajbi F, Di Bartolomeo M, Braghiroli MI, Holtved E, Ostoich SA, Kim HR, Ueno M, Mansoor W, Yang WC, Liu T, Bridgewater J, Makino T, Xynos I, Liu X, Lei M, Kondo K, Patel A, Gricar J, Chau I, Kitagawa Y; CheckMate 648 Trial Investigators. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med. 2022 Feb 3;386(5):449-462. doi: 10.1056/NEJMoa2111380."}, {"pmid"=>"33789008", "type"=>"BACKGROUND", "citation"=>"Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125. Erratum In: N Engl J Med. 2023 Feb 16;388(7):672. doi: 10.1056/NEJMx220014."}, {"pmid"=>"37488287", "type"=>"BACKGROUND", "citation"=>"Yin J, Yuan J, Li Y, Fang Y, Wang R, Jiao H, Tang H, Zhang S, Lin S, Su F, Gu J, Jiang T, Lin D, Huang Z, Du C, Wu K, Tan L, Zhou Q. Neoadjuvant adebrelimab in locally advanced resectable esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2023 Aug;29(8):2068-2078. doi: 10.1038/s41591-023-02469-3. Epub 2023 Jul 24. Erratum In: Nat Med. 2023 Sep;29(9):2376. doi: 10.1038/s41591-023-02511-4."}, {"pmid"=>"35338088", "type"=>"BACKGROUND", "citation"=>"Liu J, Yang Y, Liu Z, Fu X, Cai X, Li H, Zhu L, Shen Y, Zhang H, Sun Y, Chen H, Yu B, Zhang R, Shao J, Zhang M, Li Z. Multicenter, single-arm, phase II trial of camrelizumab and chemotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma. J Immunother Cancer. 2022 Mar;10(3):e004291. doi: 10.1136/jitc-2021-004291. Erratum In: J Immunother Cancer. 2022 Jun;10(6):e004291corr1. doi: 10.1136/jitc-2021-004291corr1."}, {"pmid"=>"35307972", "type"=>"BACKGROUND", "citation"=>"Solomon B, Callejo A, Bar J, Berchem G, Bazhenova L, Saintigny P, Wunder F, Raynaud J, Girard N, Lee JJ, Sulaiman R, Prouse B, Bresson C, Ventura H, Magidi S, Rubin E, Young B, Onn A, Leyland-Jones B, Schilsky RL, Lazar V, Felip E, Kurzrock R. A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer. Cancer Med. 2022 Jul;11(14):2790-2800. doi: 10.1002/cam4.4635. Epub 2022 Mar 20."}, {"pmid"=>"36279618", "type"=>"BACKGROUND", "citation"=>"Dennis MJ, Sacco AG, Qi Y, Bykowski J, Pittman E, Chen R, Messer K, Cohen EEW, Gold KA. A phase I study of avelumab, palbociclib, and cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma. Oral Oncol. 2022 Dec;135:106219. doi: 10.1016/j.oraloncology.2022.106219. Epub 2022 Oct 21."}, {"pmid"=>"34562395", "type"=>"BACKGROUND", "citation"=>"Mody MD, Rocco JW, Yom SS, Haddad RI, Saba NF. Head and neck cancer. Lancet. 2021 Dec 18;398(10318):2289-2299. doi: 10.1016/S0140-6736(21)01550-6. Epub 2021 Sep 22."}, {"pmid"=>"18784101", "type"=>"BACKGROUND", "citation"=>"Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. 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Nat Commun. 2022 Sep 14;13(1):5378. doi: 10.1038/s41467-022-33080-8."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(PD-L1) immunotherapy, Adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.\n\n * The primary tumor should be located in the thorax.\n * The patients should be evaluated to be able to have surgical resection before the surgery according to the examinations .\n2. The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.\n3. The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.\n\nExclusion Criteria:\n\n1. The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected.\n2. Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy.\n3. History of other malignancies.\n4. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.\n5. Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.\n6. Presence of serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart diseases, etc.\n7. The patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy, are excluded from the study.\n8. Female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded.\n9. Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.\n10. Any other factors that are not suitable for inclusion in this study judged by investigators."}, "identificationModule"=>{"nctId"=>"NCT06225921", "briefTitle"=>"Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas", "organization"=>{"class"=>"OTHER", "fullName"=>"West China Hospital"}, "officialTitle"=>"The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial", "orgStudyIdInfo"=>{"id"=>"2024-5"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Adebrelimab+Dalpiciclib(100mg)", "description"=>"Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.\n\nDalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.\n\nFor dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.", "interventionNames"=>["Drug: Adebrelimab", "Drug: Dalpiciclib 100mg"]}, {"type"=>"EXPERIMENTAL", "label"=>"Adebrelimab+Dalpiciclib(150mg)", "description"=>"Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.\n\nDalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.\n\nFor dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.", "interventionNames"=>["Drug: Adebrelimab", "Drug: Dalpiciclib 150mg"]}], "interventions"=>[{"name"=>"Adebrelimab", "type"=>"DRUG", "description"=>"Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.", "armGroupLabels"=>["Adebrelimab+Dalpiciclib(100mg)", "Adebrelimab+Dalpiciclib(150mg)"]}, {"name"=>"Dalpiciclib 100mg", "type"=>"DRUG", "description"=>"Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.", "armGroupLabels"=>["Adebrelimab+Dalpiciclib(100mg)"]}, {"name"=>"Dalpiciclib 150mg", "type"=>"DRUG", "description"=>"Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.", "armGroupLabels"=>["Adebrelimab+Dalpiciclib(150mg)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"610041", "city"=>"Chengdu", "state"=>"Sichuan", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Jin Zhou, MD.,PhD.", "role"=>"CONTACT", "email"=>"zhoujin096@scu.edu.cn", "phone"=>"+8613880626596"}, {"name"=>"Shangwei Sun", "role"=>"CONTACT", "email"=>"sunshangwei@stu.scu.edu.cn", "phone"=>"+8615291996883"}], "facility"=>"West China Hospital, Sichuan University", "geoPoint"=>{"lat"=>30.66667, "lon"=>104.06667}}], "centralContacts"=>[{"name"=>"Jin Zhou, MD.,PhD.", "role"=>"CONTACT", "email"=>"zhoujin096@scu.edu.cn", "phone"=>"+8613880626596"}, {"name"=>"Shangwei Sun", "role"=>"CONTACT", "email"=>"sunshangwei@stu.scu.edu.cn", "phone"=>"+8615291996883"}], "overallOfficials"=>[{"name"=>"Jin Zhou, MD.,PhD.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"West China Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"West China Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"professor", "investigatorFullName"=>"Xingchen Peng", "investigatorAffiliation"=>"West China Hospital"}}}}
