**3.4 Ongoing trial for BCG naïve NMIBC: GEMDOCE trial**

A phase II, two-stage, open-label trial for studying the safety and efficacy of gemcitabine docetaxel combination has started recruitment from Jul 29, 2020. The estimated enrolment is 26 patients, and the estimated completion is June 2024. The drug combination and dosing being used is 1 g gemcitabine in 50 ml sterile water; instilled once weekly for six weeks and then once monthly for ≤21 months and 37.5 mg docetaxel in 50 ml normal saline solution [NSS]; instilled once weekly for six weeks and then once monthly for ≤21 months. The primary objective is three months' complete response rate as assessed by cystoscopy and cytology. [ClinicalTrials.gov Identifier: NCT04386746] [24].
