Urine Omics Predicting IO Therapy Responses in mUC Patients

Summary

The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma.

Eligibility

Inclusion Criteria:

* 1\. Age \> 20 years
* 2\. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
* 3\. Subjects who are about to receive IO-based therapy
* 4\. ECOG performance 0, 1, 2, and 3
* 5\. Life expectancy 3 months
* 6\. eGFR \> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
* 7\. Willing to sign the informed consent form

Exclusion Criteria:

* 1\. Subjects NOT willing to sign the informed consent form
* 2\. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
* 3\. Subjects having co-existing other malignancies that need active treatment. Those with other malignancies that do not need active treatment are allowed to join the study.
* 4\. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
* 5\. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
* 6\. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for \>12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy are allowed to join the study.

Conditions2

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