Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis … (NCT04570410) | Clinical Trial Compass
CompletedPhase 2
Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma
China30 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 en…
What they're measuring
1
Pathological complete response (ypT0N0)
Timeframe: From treatment to surgery
Trial details
NCT IDNCT04570410
SponsorThe First Affiliated Hospital with Nanjing Medical University