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

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ClinicalTrials.gov Identifier: NCT04570410
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Bladder Urothelial Carcinoma Procedure: primary focal resection plus lymph node dissection Drug: Tislelizumab Drug: Gemcitabine plus cisplatin Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Trials of Primary Excision Combined With Preoperative Neoadjuvant Therapy and Adjuvant Therapy Was Used as a First-line Comprehensive Therapy for Oligometastasis of Urothelial Carcinoma(UC).
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : December 1, 2024


Arm Intervention/treatment
Experimental: Subgroup1:Patients who can tolerate cisplatin chemotherapy

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 6 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
Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma

Drug: Tislelizumab
Tislelizumab IV infusion of 200 mg Q3W
Other Name: PD-1

Drug: Gemcitabine plus cisplatin
GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks
Other Name: GC

Experimental: Subgroup2:Patients who cannot tolerate cisplatin chemotherapy

Tislelizumab Participants receive Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 6 months after excision of the primary lesion.

Intervention/treatment: Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W

Procedure: primary focal resection plus lymph node dissection
Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma

Drug: Tislelizumab
Tislelizumab IV infusion of 200 mg Q3W
Other Name: PD-1




Primary Outcome Measures :
  1. 1 year overall survival(OS) rate [ Time Frame: 1 year ]
    the percentage of patients who die of any cause within first year of treatment


Secondary Outcome Measures :
  1. progression-free survival(PFS) [ Time Frame: through study completion, an average of 1 year ]
    time between the first objective recording of PD(progressive disease) or death from any cause (whichever occurs first) from random group solstice



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with oligometastatic urothelial carcinoma, including :patients with T2-T4 with any metastasis(T4NxM1) urothelial carcinoma diagnosed by pathology and evaluated by imaging; 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.The researchers assessed the benefits of excision of the primary lesion.
  • 18 to 75 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.

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570410


Contacts
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Contact: Qikai Wu 18855179805 wuqikaidd@163.com
Contact: Pengchao Li

Locations
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China, Jiangsu
The first affiliated hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Qiang Lu, PhD    13505196501    dxhlvqiang@163.com   
Contact: Pengchao Li, PhD    13584025756    superkulian@aliyun.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Qiang Lv The First Affiliated Hospital with Nanjing Medical University
Publications:
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, Compérat 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, Grubmüller 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-Espinós E, Løgager V, Lorch A, Loriot Y, Meijer R, Carmen Mir M, Moschini M, Mostafid H, Müller AC, Müller 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, Rouprêt M, Rouvière 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, Veskimäe 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 Committees†. Ann Oncol. 2019 Nov 1;30(11):1697-1727. doi: 10.1093/annonc/mdz296.

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04570410    
Other Study ID Numbers: 2020-SR-264
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Oligometastasis
PD-1
Gemcitabine plus cisplatin
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs