NCT05038813

Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma(ESCC)

A Single-arm, Multi-center Exploratory Clinical Study of Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness and safety of anlotinib combined with TQB2450 (PD-L1 inhibitor) in the first-line treatment of patients with advanced ESCC.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib+TQB2450	Anlotinib: 12mg, orally once a day (orally before breakfast, the daily medication time should be as the same as possible), continuous taking for 2 weeks, stopping for 1 week, 3 weeks (21 days) as a treatment cycle, until the disease progresses or Intolerable. TQB2450: 1200mg, diluted to 250mL with normal saline, infusion time 60±10mins. The medication is taken on the first day of each cycle, and 3 weeks (21 days) is a treatment cycle. Until the emergence of disease progression or intolerable toxicity, the longest use time does not exceed 24 months.

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-03-01
• Completion: 2024-09-01
• First posted: 2021-09-09
• Last updated: 2023-05-18

Locations

5 sites across 1 country: China