Overview
Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma
Status:
Recruiting
Recruiting
Trial end date:
2024-12-01
2024-12-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical UniversityTreatments:
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.)