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treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-programmed cell death 1(PD-1) for Oligometastasis of urothelial carcinoma.
The study is designed to demonstrate that Whether the perioperative comprehensive treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-PD-1 can prolong the overall survival of patients, narrow the range of metastatic lesions and improve the quality of life of patients.
Compared with patients with extensive metastasis, 2-year tumor-specific survival and overall survival of patients with oligometastatic bladder cancer were significantly increased (53.3% vs 16.1%);(51.9% vs. 15.4%).Gemcitabine plus cisplatin (GC) regimen has been shown to bring clinical benefits in neoadjuvant therapy of metastatic UC(urothelial carcinoma).
PD-1 inhibitors have been widely used in urothelial carcinoma in recent years, and positive data have been obtained in both advanced patients and neoadjuvant patients.
If successful in this trial, it will serve to provide a therapeutic alternative for this patient who have oligometastasis of urothelial carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC plus Tislelizumab combined with RC | Experimental | GC plus Tislelizumab Participants receive GC (Gemcitabine plus cisplatin), in combination with Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 12 months after excision of the primary lesion. Intervention/treatment: Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W Biological: GC GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| primary focal resection plus lymph node dissection | Procedure | Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (ypT0N0) | Pathological confirmation is ypT0N0 | From treatment to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological downstaging | Pathological confirmation is \ | From treatment to surgery |
| progression-free survival(PFS) | time between the first objective recording of PD(progressive disease) or death from any cause (whichever occurs first) from first treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiang Lv | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Nanjing Medical University | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32767693 | Background | Erratum: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. Epub 2020 Apr 6. No abstract available. | |
| 15947569 | Background | Rosenberg JE, Carroll PR, Small EJ. Update on chemotherapy for advanced bladder cancer. J Urol. 2005 Jul;174(1):14-20. doi: 10.1097/01.ju.0000162039.38023.5f. |
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| Tislelizumab | Drug | Tislelizumab IV infusion of 200 mg Q3W |
|
|
| Gemcitabine plus cisplatin | Drug | GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks |
|
|
| through study completion, an average of 1 year |
| Overall survival (OS) | time between death (any causes) from first treatment. | through study completion, an average of 1 year |
| 10506615 | Background | Bajorin DF, Dodd PM, Mazumdar M, Fazzari M, McCaffrey JA, Scher HI, Herr H, Higgins G, Boyle MG. Long-term survival in metastatic transitional-cell carcinoma and prognostic factors predicting outcome of therapy. J Clin Oncol. 1999 Oct;17(10):3173-81. doi: 10.1200/JCO.1999.17.10.3173. |
| 7799047 | Background | Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available. |
| 27269944 | Background | Seisen T, Sun M, Leow JJ, Preston MA, Cole AP, Gelpi-Hammerschmidt F, Hanna N, Meyer CP, Kibel AS, Lipsitz SR, Nguyen PL, Bellmunt J, Choueiri TK, Trinh QD. Efficacy of High-Intensity Local Treatment for Metastatic Urothelial Carcinoma of the Bladder: A Propensity Score-Weighted Analysis From the National Cancer Data Base. J Clin Oncol. 2016 Oct 10;34(29):3529-3536. doi: 10.1200/JCO.2016.66.7352. |
| 29180897 | Background | Dong F, Shen Y, Gao F, Xu T, Wang X, Zhang X, Zhong S, Zhang M, Chen S, Shen Z. Prognostic value of site-specific metastases and therapeutic roles of surgery for patients with metastatic bladder cancer: a population-based study. Cancer Manag Res. 2017 Nov 14;9:611-626. doi: 10.2147/CMAR.S148856. eCollection 2017. |
| 31740927 | Background | Horwich A, Babjuk M, Bellmunt J, Bruins HM, De Reijke TM, De Santis M, Gillessen S, James N, Maclennan S, Palou J, Powles T, Ribal MJ, Shariat SF, Van Der Kwast T, Xylinas E, Agarwal N, Arends T, Bamias A, Birtle A, Black PC, Bochner BH, Bolla M, Boormans JL, Bossi A, Briganti A, Brummelhuis I, Burger M, Castellano D, Cathomas R, Chiti A, Choudhury A, Comperat E, Crabb S, Culine S, De Bari B, DeBlok W, De Visschere PJL, Decaestecker K, Dimitropoulos K, Dominguez-Escrig JL, Fanti S, Fonteyne V, Frydenberg M, Futterer JJ, Gakis G, Geavlete B, Gontero P, Grubmuller B, Hafeez S, Hansel DE, Hartmann A, Hayne D, Henry AM, Hernandez V, Herr H, Herrmann K, Hoskin P, Huguet J, Jereczek-Fossa BA, Jones R, Kamat AM, Khoo V, Kiltie AE, Krege S, Ladoire S, Lara PC, Leliveld A, Linares-Espinos E, Logager V, Lorch A, Loriot Y, Meijer R, Carmen Mir M, Moschini M, Mostafid H, Muller AC, Muller CR, N'Dow J, Necchi A, Neuzillet Y, Oddens JR, Oldenburg J, Osanto S, Oyen WJG, Pacheco-Figueiredo L, Pappot H, Patel MI, Pieters BR, Plass K, Remzi M, Retz M, Richenberg J, Rink M, Roghmann F, Rosenberg JE, Roupret M, Rouviere O, Salembier C, Salminen A, Sargos P, Sengupta S, Sherif A, Smeenk RJ, Smits A, Stenzl A, Thalmann GN, Tombal B, Turkbey B, Vahr Lauridsen S, Valdagni R, Van Der Heijden AG, Van Poppel H, Vartolomei MD, Veskimae E, Vilaseca A, Vives Rivera FA, Wiegel T, Wiklund P, Williams A, Zigeuner R, Witjes JA. EAU-ESMO consensus statements on the management of advanced and variant bladder cancer-an international collaborative multi-stakeholder effort: under the auspices of the EAU and ESMO Guidelines Committeesdagger. Ann Oncol. 2019 Nov 1;30(11):1697-1727. doi: 10.1093/annonc/mdz296. |
| 29340094 | Background | Ogihara K, Kikuchi E, Watanabe K, Kufukihara R, Yanai Y, Takamatsu K, Matsumoto K, Hara S, Oyama M, Monma T, Masuda T, Hasegawa S, Oya M. Can urologists introduce the concept of "oligometastasis" for metastatic bladder cancer after total cystectomy? Oncotarget. 2017 Dec 4;8(67):111819-111835. doi: 10.18632/oncotarget.22911. eCollection 2017 Dec 19. |
| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| C000707970 | tislelizumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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