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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Gemcitabine

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.)