Phase
Condition
Carcinoma
Urothelial Tract Cancer
Urothelial Cancer
Treatment
Systematic therapy combined with radiotherapy
Systematic drug treatment
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with metastatic uroepithelial cancer with histologically confirmeddiagnosis (pathologically confirmed primary focus or one of the metastatic foci issufficient) (metastasis after total cystectomy, metastasis after full-lengthnephroureteral resection, or metastatic uroepithelial cancer of the pelvic-ureteralbladder at the first diagnosis of inoperable metastatic uroepithelial cancer).
Oligometastases were defined as ≤3 organs, and the number and size of metastaticlesions were not restricted to the extent that full-coverage radiotherapy could bemet. If regional lymph node recurrence was present, all positive regional lymphnodes were collectively referred to as one lesion. Non-regional lymph nodemetastases are counted as metastases by lymph node subregion.
Willing and able to provide written informed consent/assent for the trial; age ≥18years on the date of signing the informed consent form and patient age ≤80 years.
Expected survival time ≥ 6 months;
Eastern Collaborative Oncology Group (ECOG) Physical Status (PS) score of 0 to 1;
Normal major organ function, i.e., the following criteria are met: routine bloodtests: a) Haemoglobin ≥ 90 g/L; b) Total bilirubin ≤ 2 x upper limit of normal (ULN); c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkalinephosphatase (ALP) ≤ 2.5 x ULN in the absence of liver metastases, and ALT, AST andALP ≤ 5 x ULN in the presence of liver metastases; d) Creatinine clearance (CrCl) ≥30 mL/min;
Exclusion
Exclusion Criteria:
Pathological type non-urothelial carcinoma;
Patients with brain metastases and >3 liver metastases; patients with spinal bonemetastases at risk of spinal cord compression; patients with pericardial, pleural orabdominopelvic fluid;
Patients who are intolerant to or have had a reduction in systemic therapy; patientswith tumour progression assessed after 2 cycles of systemic therapy.
Study Design
Study Description
Connect with a study center
Departmeng of Urology, Peking University First Hospital
Beijing,
ChinaActive - Recruiting
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing,
ChinaActive - Recruiting
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