Bladder Urothelial Carcinoma Clinical Trial
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).
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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; - 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. Local lymph node metastasis includes: A. for tumors of the bladder and lower ureter, the short diameter of pelvic lymph nodes was =8 mm B. for tumors of the renal pelvis and upper ureter, the short diameter of renal hilar 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. 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.) |
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 year overall survival(OS) rate | the percentage of patients who die of any cause within first year of treatment | 1 year | |
Secondary | progression-free survival(PFS) | time between the first objective recording of PD(progressive disease) or death from any cause (whichever occurs first) from random group solstice | through study completion, an average of 1 year |
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