Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma
NCT05030077 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2021-09-01
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.
Conditions
- Urothelial Carcinoma
- Anlotinib
- Urogenital Neoplasms
- Cisplatin
- Carboplatin
- Gemcitabine
- Antineoplastic Agents
Interventions
- DRUG
-
Anlotinib(12mg) oral daily for days 1-14, 21 days per cycle
- DRUG
-
Cisplatin (70 mg/m2) IV day 1
- DRUG
-
If the patients can't tolerate cisplatin, they will be treated with carboplatin (AUC 4.5mg/mL·min) IV day 1
- DRUG
-
Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Sponsors & Collaborators
-
Tianjin Medical University Second Hospital
lead OTHER
Principal Investigators
-
Yuanjie Niu, MD,PhD · Tianjin Medical Unversity Second Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-01
- Primary Completion
- 2023-09-01
- Completion
- 2024-09-01
Countries
- China
Study Locations
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