Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT07156058
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-Free Survival (RFS)', 'timeFrame': 'Through study completion, an expected average of 2 year.', 'description': 'The interval from surgery to diagnosis of recurrence in the patients enrolled.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Through study completion, an expected average of 2 year.', 'description': 'The interval from randomization until death, whichever comes first.'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'Through study completion, an expected average of 2 year.', 'description': 'The time from randomization to initial occurrence (including local recurrence, metastasis, second primary cancer, death or any cause among the above), whichever comes first.'}, {'measure': 'Non-recurrence after radical surgery for BTC in 2 years', 'timeFrame': 'Through study completion, an expected average of 2 year.', 'description': 'The ratio of patients with BTC after radical surgery without recurrence in 2 years.'}, {'measure': 'Quality of Life (QOL)', 'timeFrame': 'Through study completion, an expected average of 2 year.', 'description': 'Assessed by the EORTC QLQ-C30 for patients over 16 years old) or the Pediatric Quality of Life Inventory (PedsQL) for patients under 16 years old.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract Cancer']}, 'referencesModule': {'references': [{'pmid': '33516341', 'type': 'BACKGROUND', 'citation': 'Valle JW, Kelley RK, Nervi B, Oh DY, Zhu AX. Biliary tract cancer. Lancet. 2021 Jan 30;397(10272):428-444. doi: 10.1016/S0140-6736(21)00153-7.'}, {'pmid': '32602010', 'type': 'BACKGROUND', 'citation': 'Mizrahi JD, Shroff RT. New Treatment Options for Advanced Biliary Tract Cancer. Curr Treat Options Oncol. 2020 Jun 29;21(8):63. doi: 10.1007/s11864-020-00767-3.'}, {'pmid': '31431036', 'type': 'BACKGROUND', 'citation': 'Mondaca S, Nervi B, Pinto M, Abou-Alfa GK. Biliary tract cancer prognostic and predictive genomics. Chin Clin Oncol. 2019 Aug;8(4):42. doi: 10.21037/cco.2019.07.06. Epub 2019 Jul 29.'}, {'pmid': '33037430', 'type': 'BACKGROUND', 'citation': 'Nara S, Esaki M, Ban D, Takamoto T, Shimada K, Ioka T, Okusaka T, Ishii H, Furuse J. Adjuvant and neoadjuvant therapy for biliary tract cancer: a review of clinical trials. Jpn J Clin Oncol. 2020 Dec 16;50(12):1353-1363. doi: 10.1093/jjco/hyaa170.'}, {'pmid': '27249723', 'type': 'BACKGROUND', 'citation': 'Bridgewater JA, Goodman KA, Kalyan A, Mulcahy MF. Biliary Tract Cancer: Epidemiology, Radiotherapy, and Molecular Profiling. Am Soc Clin Oncol Educ Book. 2016;35:e194-203. doi: 10.1200/EDBK_160831.'}, {'pmid': '34551663', 'type': 'BACKGROUND', 'citation': 'Persano M, Puzzoni M, Ziranu P, Pusceddu V, Lai E, Pretta A, Donisi C, Pinna G, Spanu D, Cimbro E, Parrino A, Liscia N, Mariani S, Dubois M, Migliari M, Scartozzi M. Molecular-driven treatment for biliary tract cancer: the promising turning point. Expert Rev Anticancer Ther. 2021 Nov;21(11):1253-1264. doi: 10.1080/14737140.2021.1982699. Epub 2021 Sep 24.'}, {'pmid': '32171892', 'type': 'BACKGROUND', 'citation': 'Lamarca A, Barriuso J, McNamara MG, Valle JW. Molecular targeted therapies: Ready for "prime time" in biliary tract cancer. J Hepatol. 2020 Jul;73(1):170-185. doi: 10.1016/j.jhep.2020.03.007. Epub 2020 Mar 12.'}, {'pmid': '35839428', 'type': 'BACKGROUND', 'citation': 'Scott AJ, Sharman R, Shroff RT. Precision Medicine in Biliary Tract Cancer. J Clin Oncol. 2022 Aug 20;40(24):2716-2734. doi: 10.1200/JCO.21.02576. Epub 2022 Jul 15.'}, {'pmid': '30257718', 'type': 'BACKGROUND', 'citation': 'Zhang F, Wang W, Long Y, Liu H, Cheng J, Guo L, Li R, Meng C, Yu S, Zhao Q, Lu S, Wang L, Wang H, Wen D. Characterization of drug responses of mini patient-derived xenografts in mice for predicting cancer patient clinical therapeutic response. Cancer Commun (Lond). 2018 Sep 26;38(1):60. doi: 10.1186/s40880-018-0329-5.'}, {'pmid': '24190964', 'type': 'BACKGROUND', 'citation': 'Raja FA, Counsell N, Colombo N, Pfisterer J, du Bois A, Parmar MK, Vergote IB, Gonzalez-Martin A, Alberts DS, Plante M, Torri V, Ledermann JA. Platinum versus platinum-combination chemotherapy in platinum-sensitive recurrent ovarian cancer: a meta-analysis using individual patient data. Ann Oncol. 2013 Dec;24(12):3028-34. doi: 10.1093/annonc/mdt406. Epub 2013 Nov 4.'}, {'pmid': '29472484', 'type': 'BACKGROUND', 'citation': 'Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.'}, {'pmid': '29625057', 'type': 'BACKGROUND', 'citation': 'Lee SH, Hu W, Matulay JT, Silva MV, Owczarek TB, Kim K, Chua CW, Barlow LJ, Kandoth C, Williams AB, Bergren SK, Pietzak EJ, Anderson CB, Benson MC, Coleman JA, Taylor BS, Abate-Shen C, McKiernan JM, Al-Ahmadie H, Solit DB, Shen MM. Tumor Evolution and Drug Response in Patient-Derived Organoid Models of Bladder Cancer. Cell. 2018 Apr 5;173(2):515-528.e17. doi: 10.1016/j.cell.2018.03.017.'}, {'pmid': '29224780', 'type': 'BACKGROUND', 'citation': 'Sachs N, de Ligt J, Kopper O, Gogola E, Bounova G, Weeber F, Balgobind AV, Wind K, Gracanin A, Begthel H, Korving J, van Boxtel R, Duarte AA, Lelieveld D, van Hoeck A, Ernst RF, Blokzijl F, Nijman IJ, Hoogstraat M, van de Ven M, Egan DA, Zinzalla V, Moll J, Boj SF, Voest EE, Wessels L, van Diest PJ, Rottenberg S, Vries RGJ, Cuppen E, Clevers H. A Living Biobank of Breast Cancer Organoids Captures Disease Heterogeneity. Cell. 2018 Jan 11;172(1-2):373-386.e10. doi: 10.1016/j.cell.2017.11.010. Epub 2017 Dec 7.'}, {'pmid': '27641504', 'type': 'BACKGROUND', 'citation': "Bruna A, Rueda OM, Greenwood W, Batra AS, Callari M, Batra RN, Pogrebniak K, Sandoval J, Cassidy JW, Tufegdzic-Vidakovic A, Sammut SJ, Jones L, Provenzano E, Baird R, Eirew P, Hadfield J, Eldridge M, McLaren-Douglas A, Barthorpe A, Lightfoot H, O'Connor MJ, Gray J, Cortes J, Baselga J, Marangoni E, Welm AL, Aparicio S, Serra V, Garnett MJ, Caldas C. A Biobank of Breast Cancer Explants with Preserved Intra-tumor Heterogeneity to Screen Anticancer Compounds. Cell. 2016 Sep 22;167(1):260-274.e22. doi: 10.1016/j.cell.2016.08.041. Epub 2016 Sep 15."}, {'pmid': '17606733', 'type': 'BACKGROUND', 'citation': 'Marangoni E, Vincent-Salomon A, Auger N, Degeorges A, Assayag F, de Cremoux P, de Plater L, Guyader C, De Pinieux G, Judde JG, Rebucci M, Tran-Perennou C, Sastre-Garau X, Sigal-Zafrani B, Delattre O, Dieras V, Poupon MF. A new model of patient tumor-derived breast cancer xenografts for preclinical assays. Clin Cancer Res. 2007 Jul 1;13(13):3989-98. doi: 10.1158/1078-0432.CCR-07-0078.'}, {'pmid': '26536825', 'type': 'BACKGROUND', 'citation': 'Friedman AA, Letai A, Fisher DE, Flaherty KT. Precision medicine for cancer with next-generation functional diagnostics. Nat Rev Cancer. 2015 Dec;15(12):747-56. doi: 10.1038/nrc4015. Epub 2015 Nov 5.'}, {'pmid': '25304260', 'type': 'BACKGROUND', 'citation': 'Ricci F, Bizzaro F, Cesca M, Guffanti F, Ganzinelli M, Decio A, Ghilardi C, Perego P, Fruscio R, Buda A, Milani R, Ostano P, Chiorino G, Bani MR, Damia G, Giavazzi R. 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Personalized treatment based on mini patient-derived xenografts and WES/RNA sequencing in a patient with metastatic duodenal adenocarcinoma. Cancer Commun (Lond). 2018 Aug 23;38(1):54. doi: 10.1186/s40880-018-0323-y.'}, {'pmid': '33141330', 'type': 'BACKGROUND', 'citation': 'Yang L, Yuan Z, Zhang Y, Cui Z, Li Y, Hou J, Liu X, Liu Z, Shi R, Tian Q, Wang J, Wang L. MiniPDX-guided postoperative anticancer treatment can effectively prolong the survival of patients with hepatocellular carcinoma. Cancer Chemother Pharmacol. 2021 Jan;87(1):125-134. doi: 10.1007/s00280-020-04182-1. Epub 2020 Nov 3.'}, {'pmid': '33833569', 'type': 'BACKGROUND', 'citation': 'Huang Y, Xu J, Li K, Wang J, Dai Y, Kang Y. A Novel, Personalized Drug-Screening System for Platinum-Resistant Ovarian Cancer Patients: A Preliminary Clinical Report. Cancer Manag Res. 2021 Mar 29;13:2849-2867. doi: 10.2147/CMAR.S276799. eCollection 2021.'}, {'pmid': '32888432', 'type': 'BACKGROUND', 'citation': 'Li C, Sun YD, Yu GY, Cui JR, Lou Z, Zhang H, Huang Y, Bai CG, Deng LL, Liu P, Zheng K, Wang YH, Wang QQ, Li QR, Wu QQ, Liu Q, Shyr Y, Li YX, Chen LN, Wu JR, Zhang W, Zeng R. Integrated Omics of Metastatic Colorectal Cancer. Cancer Cell. 2020 Nov 9;38(5):734-747.e9. doi: 10.1016/j.ccell.2020.08.002. Epub 2020 Sep 3.'}, {'pmid': '33493586', 'type': 'BACKGROUND', 'citation': 'Wang J, Sun T, Meng Z, Wang L, Li M, Chen J, Qin T, Yu J, Zhang M, Bie Z, Dong Z, Jiang X, Lin L, Zhang C, Liu Z, Jiang R, Yang G, Li L, Zhang Y, Huang D. XPO1 inhibition synergizes with PARP1 inhibition in small cell lung cancer by targeting nuclear transport of FOXO3a. Cancer Lett. 2021 Apr 10;503:197-212. doi: 10.1016/j.canlet.2021.01.008. Epub 2021 Jan 23.'}, {'pmid': '33945662', 'type': 'BACKGROUND', 'citation': 'Wang X, Sun Y, Xu Y, Wen D, An N, Leng X, Fu G, Lu S, Chen Z. Mini-patient-derived xenograft assay based on microfluidic technology promises to be an effective tool for screening individualized chemotherapy regimens for advanced non-small cell lung cancer. Cell Biol Int. 2021 Sep;45(9):1887-1896. doi: 10.1002/cbin.11622. Epub 2021 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer.', 'detailedDescription': 'Biliary tract cancer (BTC) is the most common primary malignancy of the biliary tract. Currently, surgery provides the only ray of hope for the management of BTC, however, the disease is progressing rapidly, lacking of obvious symptoms in its early stages, with metastases to lymph nodes. Only 20-30% of patients are eligible for surgical resection with curative intent. In addition, the treatment remains difficult because of the lack of effective chemotherapeutic agents and the combined regimens for reference.\n\nIn this study, fresh tumor samples generated directly from patients will be used for a MiniPDX test and inoculated in mice subcutaneously. The candidate drugs or regimens can be tested in mice to determine the best treatment for that specific patient after surgery.\n\nThe study aims to evaluate the efficacy and accuracy of MiniPDX assays for antitumor chemotherapeutics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. histologically documented biliary duct cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma and gallbladder carcinoma). Patients underwent R0 resection.\n2. Ambulatory male or female. Age ≥ 18 years.\n3. ECOG performance status between 0 and 2\n4. Patients must be tolerated with combination treatment with life expectancy of greater than 6 months.\n5. No dysfunction and bleeding tendency in main organs (heart, liver, brain and kidneys); No history of blood disease; No cardiac insufficiency or chest pain (medically uncontrollable). No myocardial infarction occurred within 12 months before the start of the study.\n6. Subjects must have normal organ as defined below: Hb ≥80 g/L; ANC ≥1.5×109/L; Platelets ≥100×109/L; AL/AST ≤2.5 x institutional upper limit of normal; ALP ≤2.5 x ULN; Total bilirubin \\<1.5 x ULN; Creatinine \\<1 x ULN; Serum albumin ≥30g/L.\n7. Women of child-bearing potential must agree to use adequate contraception (IUD, contraceptives or condoms) for the duration of study participation, and for 6 months after completion of study; Serum or urine pregnancy tests are negative within 7 days before study entry; men must agree to use adequate contraception for the duration of study participation, and for 6 months after completion of study.\n8. Patients must be willing to and able to follow the protocol during study entry.\n9. Patients must be willing to sign an informed consent and able to understand that anytime is all right to quit the study without loss.\n\nExclusion Criteria:\n\n1. Prior chemotherapy or radiotherapy.\n2. Patients are in other clinical trials.\n3. Coagulation disorders, history of blood disease or serious (active) heart disease such as coronary heart disease with apparent symptom, congestive heart failure of NYHA Class II or more severe, serious heart rhythm controlled by medicaments, or the attack of myocardial infarction within 12 months.\n4. Hepatic and renal insufficiency with apparent symptom.\n5. Pregnant or lactating female, or women of child-bearing age who have a positive serum pregnancy test or no tests. Female subjects of non-reproductive potential with post-menopausal for ≥1 year.\n6. Patients with multiple primary cancer, or brain or meningeal metastases.\n7. Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as judged by the investigator, may hinder the signing of informed consent or affect the patient's compliance with oral medication\n8. Patients who need immunotherapy for organ transplantation.\n9. Patients with recurrent infections, or other uncontrolled accompanying diseases, or hepatic cirrhosis caused hepatic injury or chronic active hepatitis (ALT ≥2 ULN, AST ≥1.5 ULN, PT \\>13 S or TB ≥2 ULN)\n10. Moderate or severe kidney injury \\[CrCl ≤50 ml/min (Cockcroft-Gault Equation)\\], or creatinine \\> ULN"}, 'identificationModule': {'nctId': 'NCT07156058', 'briefTitle': 'MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'LC2022A04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MiniPDX group', 'description': '102 patients with BTC after surgery will be treated with drugs or regimens tested by MiniPDX assays.', 'interventionNames': ['Other: MiniPDX group']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Treatment of Physician's Choice (TPC)", 'description': 'TPC will be administered per standard of care. 102 patients after surgery in the same period will receive chemotherapy.', 'interventionNames': ['Drug: Capecitabine']}], 'interventions': [{'name': 'MiniPDX group', 'type': 'OTHER', 'description': 'Personalized treatment for guided by mini-PDX. The MiniPDX test can provide drug sensitivity results in as little as 7 days. Drugs including but not limited to the following agents: capecitabine, gemcitabine + cis-platinum, gemcitabine + capecitabine, 5-FU + oxaliplatin, gemcitabine, 5-FU, capecitabine + cis-platinum, 5-FU + cis-platinum.', 'armGroupLabels': ['MiniPDX group']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Drug: Capecitabine', 'armGroupLabels': ["Treatment of Physician's Choice (TPC)"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinyu Bi, M.D.', 'role': 'CONTACT'}], 'facility': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xinyu Bi, M.D.', 'role': 'CONTACT', 'email': 'beexy1971@163.com', 'phone': '13911792177'}], 'overallOfficials': [{'name': 'Xinyu Bi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}