NCT05866510

Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer

A Multicenter, Single-arm, Exploratory Clinical Study of Utidelone Combined With Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer That Has Failed Standard First-line Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety, tolerance and efficacy of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who failed Standard first line therapy.

Detailed description

Patients with advanced or recurrent esophageal carcinoma who failed standard first-line therapy have a low survival prognosis. There are few treatment options available and the clinical need is great. The aim of this study is to evaluate the efficacy and safety of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who fail first line therapy. The trial is a single arm design. Patient in the treatment group will accept Utidelone at 30 mg/m2/d administered intravenously on days 1-5 and Anlotinib 8mg/d administered orally on days 1-14, 21 days as one cycle. Before the use of utidelone, all patients will accept pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after enrollment and will continue until disease progression according to RECIST v1.1 criteria. For patients with no disease progression, tumor evaluation will continue regardless of treatment discontinuation unless the patient begins new antitumor therapy or withdraws informed consent.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Utidelone and anlotinib	Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. Utidelone will be given at 30 mg/m2/d administered intravenously on days 1-5 and Anlotinib 8mg/d took orally on days 1-14 every 21 days.

Timeline

• Start date: 2023-05-15
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-05-19
• Last updated: 2023-05-19

Locations

3 sites across 1 country: China