NCT03051373View on ClinicalTrials.gov

Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract

PHASE2CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

April 1, 2017

Primary Completion Date

April 30, 2019

Study Completion Date

April 30, 2020

Conditions
Carcinoma, Transitional Cell
Interventions
DRUG

nanoparticle albumin-bound paclitaxel, S-1

Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

DRUG

Gemcitabine, cisplatin

Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

Trial Locations (1)

100022

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER

NCT03051373 - Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract | Biotech Hunter | Biotech Hunter