NCT05030077

Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma

A Single-arm, Phase II Study of Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to VEGFR, FGFR, PDGFR and c-Kit. This study intends to assess the efficacy and safety of anlotinib combined with platinum/gemcitabine for first line treatment of advanced urothelial carcinoma.

Detailed description

The primary objective is to determine the antitumor activity of anlotinib combined with platinum/gemcitabine (Objective Response rate, ORR) in patients with advanced urothelial carcinoma.

Conditions

• Urothelial Carcinoma
• Anlotinib
• Urogenital Neoplasms
• Cisplatin
• Carboplatin
• Gemcitabine
• Antineoplastic Agents

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib(12mg) oral daily for days 1-14, 21 days per cycle
DRUG	Cisplatin	Cisplatin (70 mg/m2) IV day 1
DRUG	Carboplatin	If the patients can't tolerate cisplatin, they will be treated with carboplatin (AUC 4.5mg/mL·min) IV day 1
DRUG	Gemcitabine	Gemcitabine ( 1000 mg/m2) IV days 1 and 8

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2021-09-01
• Last updated: 2021-09-01

Locations

1 site across 1 country: China