Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma

NCT04570410 | Completed Phase 2

• 1 other identifier: 2020-SR-264.A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Urothelial Carcinoma

Keywords

Oligometastasis; PD-1; Gemcitabine plus cisplatin; Simple lymph node metastasis

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (ypT0N0)

  Pathological confirmation is ypT0N0

  From treatment to surgery

Secondary Outcomes (3)

• Pathological downstaging

  From treatment to surgery

• progression-free survival(PFS)

  through study completion, an average of 1 year

• Overall survival (OS)

  through study completion, an average of 1 year

Study Arms (1)

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

Procedure: primary focal resection plus lymph node dissection; Drug: Tislelizumab; Drug: Gemcitabine plus cisplatin

Interventions

primary focal resection plus lymph node dissection PROCEDURE

Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma

GC plus Tislelizumab combined with RC

Tislelizumab DRUG

Tislelizumab IV infusion of 200 mg Q3W

Also known as: PD-1

GC plus Tislelizumab combined with RC

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

Also known as: GC

GC plus Tislelizumab combined with RC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with oligometastatic urothelial carcinoma, including :patients with T2-T4 with any metastasis urothelial carcinoma diagnosed by pathology and evaluated by imaging. 1. Patients with measurable oligometastasis or with local lymph node metastasis. Measurable oligometastasis includes: A. a solitary metastatic organ, B. number of metastatic lesions of ≤3, C. the largest diameter of metastatic foci of ≤5cm, D. absence of liver metastasis. 2. Local lymph node metastasis includes: M0 patients with the short diameter of pelvic lymph nodes was ≥8 mm. The researchers assessed the benefits of excision of the primary lesion.
• Older than 18 years old.
• Volunteer to participate in the trial, be able to provide a written informed consent, and understand and agree to comply with the study requirements and evaluation schedule.
• Eastern Cooperative Oncology Group (ECOG) performance status \<2
• International standardized ratio or activated partial thrombin time ≤1.5 upper limit of normal value (ULN);The calculated creatinine clearance rate was ≥60ml/min;Serum total bilirubin ≤1.5×ULN;aspartate transaminase(AST), Alanine transaminase(ALT) and alkaline phosphatase ≤2.5×ULN;
• Non-pregnant or fertile men or women must be willing to take effective contraceptive measures during the study period and ≥120 days after the last administration of tislelizumab, and the women should be negative on urine or serum pregnancy test results less than or equal to 7 days before enrollment.

You may not qualify if:

• Previous therapy targeted at PD-1, PD-L1, PD-L2, Cytotoxic T-Lymphocyte Associated Protein 4(CTLA-4)or other antibodies or drugs specifically targeting T cell synergistic stimulation or checkpoint channels.
• Other approved systemic anti-cancer therapies or systemic immune modulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) were received within 28 days prior to enrollment.
• Severe chronic or active infections requiring systemic antimicrobial, antifungal, or antiviral therapy within 14 days prior to enrollment.
• Major surgery or major trauma occurred within 28 days prior to enrollment.
• Live vaccine was administered within 28 days before enrollment.
• Received any herbal or proprietary Chinese medicine used to control cancer in the 14 days prior to enrollment.
• Active autoimmune disease requiring long-term use of large amounts of hormones and other immunosuppressive agents.
• The researchers identified abnormalities in potassium, sodium, calcium, or hypoalbuminemia, interstitial lung disease, non-infectious pneumonia, or other uncontrolled whole-body diseases, including diabetes, hypertension, and cardiovascular disease, that may affect treatment.
• A history of HIV, hepatitis B virus(HBV)and hepatitis C virus(HCV) infection is known.
• A history of known allergic reactions to any of the drugs studied.
• Is participating in additional clinical studies.
• The researcher believes that the patient is not suitable to participate in this study (such as the treatment that does not meet the patient's greatest benefit, patient compliance, etc.)

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (8)

• 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.

  PMID: 32767693 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.

  PMID: 15947569 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.

  PMID: 10506615 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.

  PMID: 7799047 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.

  PMID: 27269944 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.

  PMID: 29180897 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.

  PMID: 31740927 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.

  PMID: 29340094 BACKGROUND

MeSH Terms

Interventions

Lymph Node Excision; tislelizumab; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Qiang Lv

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 30, 2020
• Study Start: December 1, 2020
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)