drugset / Trial / NCT07156058
MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer.
Timeline
- Start
- 2023-01-01
- Primary completion
- 2025-08-31
- Completion
- 2025-12-31
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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. Patient-derived ovarian tumor xenografts recapitulate human clinicopathology and genetic alterations. Cancer Res. 2014 Dec 1;74(23):6980-90. doi: 10.1158/0008-5472.CAN-14-0274. Epub 2014 Oct 10.
- Background Zhan M, Yang RM, Wang H, He M, Chen W, Xu SW, Yang LH, Liu Q, Long MM, Wang J. Guided chemotherapy based on patient-derived mini-xenograft models improves survival of gallbladder carcinoma patients. Cancer Commun (Lond). 2018 Jul 17;38(1):48. doi: 10.1186/s40880-018-0318-8.
- Background Solaini L, Jamieson NB, Metcalfe M, Abu Hilal M, Soonawalla Z, Davidson BR, McKay C, Kocher HM; UK Duodenal Cancer Study Group. Outcome after surgical resection for duodenal adenocarcinoma in the UK. Br J Surg. 2015 May;102(6):676-81. doi: 10.1002/bjs.9791. Epub 2015 Mar 16.
- Background Zhao P, Chen H, Wen D, Mou S, Zhang F, Zheng S. 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | — |