Nctid:
NCT06615830
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000000230", "term"=>"Adenocarcinoma"}, {"id"=>"D000010190", "term"=>"Pancreatic Neoplasms"}], "ancestors"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M3585", "name"=>"Adenocarcinoma", "asFound"=>"Adenocarcinoma", "relevance"=>"HIGH"}, {"id"=>"M13110", "name"=>"Pancreatic Neoplasms", "asFound"=>"Pancreatic Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"T4387", "name"=>"Pancreatic Cancer", "asFound"=>"Pancreatic Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M19537", "name"=>"Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M2985", "name"=>"Gemcitabine", "relevance"=>"LOW"}, {"id"=>"M231", "name"=>"Albumin-Bound Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M271136", "name"=>"Folfirinox", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>185}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2029-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-01", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Organoid sensitivity to first-line regimens ad progression-free survival", "timeFrame"=>"From enrollment to disease progression according to the RECIST v1.1 criteria, assessed up to 100 months", "description"=>"To demonstrate a significant correlation between the degree of sensitivity predicted by PDOs to Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX (according to the SEQUENCE trial) or FOLFIRINOX (according to the NAPOLI-3 trial), and clinical progression free survival (PFS) in metastatic pancreatic adenocarcinoma."}], "secondaryOutcomes"=>[{"measure"=>"Linear versus non-linear relationship between organoid sensitivity and progression-free survival", "timeFrame"=>"From patient-derived organoid generation to completion of drug benchmarking, assessed up to 100 months", "description"=>"Explore graphically and statistically whether the relationship between PDOs sensitivity to first line regimens and PFS has a linear or non-linear shape."}, {"measure"=>"Within-subjects progression-free survival comparison", "timeFrame"=>"From patient enrollment until second disease progression according to the RECIST v1.1 criteria, assessed up to 100 months", "description"=>"Compare progression-free survival in months between second-line, targeted regimens with first-line, standard therapy."}, {"measure"=>"Linear versus non-linear relationship between organoid sensitivity and progression-free survival", "timeFrame"=>"From patient-derived organoid generation to completion of drug benchmarking assessed up to 100 months", "description"=>"Explore graphically and statistically whether the relationship between PDOs sensitivity to second-line, targeted regimens and PFS has a linear or non-linear shape."}, {"measure"=>"Quality of life", "timeFrame"=>"From enrollment to the second disease progression according to the RECIST v1.1 criteria, assessed up to 100 months", "description"=>"Assess quality of life under standard and targeted chemotherapy."}, {"measure"=>"Biobanking", "timeFrame"=>"Biological samples will be biobanked up to 5 years", "description"=>"Collect samples for biobanking and further identification of potential markers associated with tumor response (e.g. circulating tumoral DNA)."}, {"measure"=>"Rate of newly-identified compound", "timeFrame"=>"From patient-derived organoid generation to completion of drug benchmarking, through study completion, an average of 1 year", "description"=>"Assess the rate of compounds identified by patient-derived organoids, which are not routinely used by treating oncologists or accepted by insurances for reimbursement."}, {"measure"=>"Second-line, most effective regimen in vitro prediction", "timeFrame"=>"From patient-derived organoid generation to completion of drug benchmarking, through study completion, assessed up to 100 months", "description"=>"Assess, through patient-derived organoids benchmarking, the most effective second-line chemotherapeutic regimen according to the presence of genetic signatures (at DNA and RNA level) associated with treatment response."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Pancreatic cancer", "Pancreatic adenocarcinoma", "Metastatic pancreatic adenocarcinoma", "Organoid", "Organoid-driven chemotherapy"], "conditions"=>["Pancreas Neoplasms", "Pancreatic Neoplasms", "Pancreatic Cancer Metastatic", "Pancreatic Adenocarcinoma Metastatic"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8580930", "type"=>"BACKGROUND", "citation"=>"Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. J Biopharm Stat. 1995 Nov;5(3):297-306. doi: 10.1080/10543409508835115."}, {"pmid"=>"15273542", "type"=>"BACKGROUND", "citation"=>"Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae."}, {"pmid"=>"32558804", "type"=>"BACKGROUND", "citation"=>"Paluri RK, Kasi A, Young C, Posey JA. Second-line treatment for metastatic pancreatic cancer. Clin Adv Hematol Oncol. 2020 Feb;18(2):106-115."}, {"pmid"=>"34665339", "type"=>"BACKGROUND", "citation"=>"Ettrich TJ, Seufferlein T. Systemic Therapy for Metastatic Pancreatic Cancer. Curr Treat Options Oncol. 2021 Oct 19;22(11):106. doi: 10.1007/s11864-021-00895-4."}, {"pmid"=>"28353074", "type"=>"BACKGROUND", "citation"=>"Zhang XW, Ma YX, Sun Y, Cao YB, Li Q, Xu CA. Gemcitabine in Combination with a Second Cytotoxic Agent in the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer: a Systematic Review and Meta-Analysis. Target Oncol. 2017 Jun;12(3):309-321. doi: 10.1007/s11523-017-0486-5."}, {"pmid"=>"19801936", "type"=>"BACKGROUND", "citation"=>"Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection-2,804 patients. Ann Surg. 2009 Nov;250(5):831-41. doi: 10.1097/SLA.0b013e3181b0c4df."}, {"pmid"=>"17051446", "type"=>"BACKGROUND", "citation"=>"Strassburg CP, Manns MP. Approaches to liver biopsy techniques--revisited. Semin Liver Dis. 2006 Nov;26(4):318-27. doi: 10.1055/s-2006-951599."}, {"pmid"=>"36374194", "type"=>"BACKGROUND", "citation"=>"Vasciaveo A, Arriaga JM, de Almeida FN, Zou M, Douglass EF, Picech F, Shibata M, Rodriguez-Calero A, de Brot S, Mitrofanova A, Chua CW, Karan C, Realubit R, Pampou S, Kim JY, Afari SN, Mukhammadov T, Zanella L, Corey E, Alvarez MJ, Rubin MA, Shen MM, Califano A, Abate-Shen C. OncoLoop: A Network-Based Precision Cancer Medicine Framework. Cancer Discov. 2023 Feb 6;13(2):386-409. doi: 10.1158/2159-8290.CD-22-0342."}, {"pmid"=>"30430011", "type"=>"BACKGROUND", "citation"=>"Yang H, Sun L, Liu M, Mao Y. Patient-derived organoids: a promising model for personalized cancer treatment. Gastroenterol Rep (Oxf). 2018 Nov;6(4):243-245. doi: 10.1093/gastro/goy040. Epub 2018 Oct 9. No abstract available."}, {"pmid"=>"29325707", "type"=>"BACKGROUND", "citation"=>"Tiriac H, Bucobo JC, Tzimas D, Grewel S, Lacomb JF, Rowehl LM, Nagula S, Wu M, Kim J, Sasson A, Vignesh S, Martello L, Munoz-Sagastibelza M, Somma J, Tuveson DA, Li E, Buscaglia JM. Successful creation of pancreatic cancer organoids by means of EUS-guided fine-needle biopsy sampling for personalized cancer treatment. Gastrointest Endosc. 2018 Jun;87(6):1474-1480. doi: 10.1016/j.gie.2017.12.032. Epub 2018 Jan 9."}, {"pmid"=>"30834048", "type"=>"BACKGROUND", "citation"=>"Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. Epub 2019 Feb 26."}, {"pmid"=>"27956793", "type"=>"BACKGROUND", "citation"=>"Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016 Nov 28;22(44):9694-9705. doi: 10.3748/wjg.v22.i44.9694."}, {"pmid"=>"10819955", "type"=>"BACKGROUND", "citation"=>"Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701."}]}, "descriptionModule"=>{"briefSummary"=>"Pancreatic cancer is burdened by an extremely low survival rate. Survival chances reduce even further when the tumor spreads to other organs such as lymphnodes, liver or lungs. When the tumor cannot be surgically resected, the only valid curative option is represented by chemotherapy. However, therapies available to date have limited efficacy and they do not specifically target the biological characteristics of the tumor. The aim of the project is to validate a new technology called \\&#34;patient-derived organoids\\&#34; (PDOs) in predicting the best drugs for the treatment of pancreatic cancer based on the tumoral characteristics and behavior.\n\nIn order to generate PDOs a sample of tumoral tissue will be collected during a small surgical procedure, called laparoscopy. PDOs represent mini, three-dimensional copies of the original tumor, of which they maintain its behavior and aggressiveness. Through the DNA and RNA analysis of the tumor, the aim is to predict the best available drug by screening thousands of potentially effective compounds. Once identified, drugs will be tested in vitro on PDOs and the most efficient drug in controlling the tumor will be administered to the patient, once the present standard-of-care treatments fail.\n\nMultiple benefits are expected from this trial. First of all, the most effective drug against their tumor based on an objective in vitro response will be provided. This might reflect in a better control of the disease and in a longer survival. Targeting the chemotherapy will also imply less side-effects due to unnecessary elevated chemotherapeutic dosages, which in turn will lead to a better compliance with the therapy. Eventually, all these aspects will reflect into a better quality of life."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Patients older than 18 years\n* Patients with metastatic pancreatic ductal adenocarcinoma\n* At least one lesion amenable for surgical excisional biopsy\n* ECOG Performance status 0-2\n* Radiologically measurable disease\n* Life expectancy \\> 3 months\n* Absolute leucocyte count \\>1.5 G/l, platelets \\>100 G/l\n* Serum creatinine \\<1.5 times of the upper limit of normal or Clearance \\>50ml/min (according to the CKD-EPI formula)\n\nExclusion Criteria:\n\n* Known allergies or intolerance to one or more compounds present in one of the 3 first line regimens approved for the trial\n* Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy\n* ECOG PS \\>2\n* Heart failure (NYHA class III-IV)\n* Severe or uncontrolled concurrent illness\n* Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment\n* Myocardial infarction within the previous 6 months\n* Patients who are pregnant or breastfeeding"}, "identificationModule"=>{"nctId"=>"NCT06615830", "briefTitle"=>"Organoid-driven Chemotherapy Choice in Metastatic Pancreatic Cancer Patients.", "organization"=>{"class"=>"OTHER", "fullName"=>"Klinik Hirslanden, Zurich"}, "officialTitle"=>"Single-centre Phase 2 Open Label Two Independent Arms Study Assessing Organoid-driven Tumoral Chemosensitivity in Metastatic Pancreatic Cancer.", "orgStudyIdInfo"=>{"id"=>"HIPANC_002"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Organoid-driven second-line chemotherapy", "description"=>"The arm will include patients with diagnosis of metastatic pancreatic adenocarcinoma. After complete disease staging, patients will undergo laparoscopic surgical biopsy of metastatic tumoral tissue. The tissue will serve for the generation of patient-derived organoids on which potentially effective drugs will be benchmarked.\n\nEach patient will receive the standard first-line chemotherapy (chosen among Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX or FOLFIRINOX, based on the clinical judgement of the treating oncologist). Upon disease progression, the drug predicted to be the most effective agent will be implemented as second-line therapy.", "interventionNames"=>["Drug: Standard chemotherapy", "Drug: Organoid-guided treatment"]}], "interventions"=>[{"name"=>"Standard chemotherapy", "type"=>"DRUG", "description"=>"Each patient will receive the standard first-line chemotherapy (chosen among Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX or FOLFIRINOX, based on the clinical judgement of the treating oncologist) until disease progression.", "armGroupLabels"=>["Organoid-driven second-line chemotherapy"]}, {"name"=>"Organoid-guided treatment", "type"=>"DRUG", "description"=>"Upon disease progression confirmed radiologically, the patients will receive second-line chemotherapy. Second-line chemotherapy will be selected among the most promising effective drug (or drug regimens) as predicted in vitro by their benchmarking on patient-derived organoids.", "armGroupLabels"=>["Organoid-driven second-line chemotherapy"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Jan Schmidt, Prof. Dr. med. Dres. h.c. MME", "role"=>"CONTACT", "email"=>"jan.schmidt@hirslanden.ch", "phone"=>"+ 41 442092505"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Prof. Dr. med. Dres. h.c. Jan Schmidt, MME", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Klinik Hirslanden, Zurich", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Prof. Dr. med. Dres. h.c.", "investigatorFullName"=>"Prof. Dr. med. Dres. h.c. Jan Schmidt, MME", "investigatorAffiliation"=>"Klinik Hirslanden, Zurich"}}}}
