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

Korábbi kezelés

• 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.

Más betegség

• Active autoimmune disease requiring long-term use of large amounts of hormones and other immunosuppressive agents.
• 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.

Laborértékek

• 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.
• 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.

Egyéb

• 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.)

• 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.