NCT06512428

A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma

An Open-label, Multicenter Phase II Clinical Trial to Explore the Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Patients With Advanced Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.

Detailed description

The experiment was divided into two stages. The first stage is dose escalation stage. Rapid titration and "3+3" dose escalation design were used to observe DLT of simmitinib plus irinotecan liposome, and MTD was determined. The second stage is a randomized controlled study. After RP2D was determined in the first stage, participants were randomly assigned to 3 groups in a 1:1:1 ratio, including simmitinib plus irinotecan liposome, irinotecan liposome, and irinotecan.

Conditions

• Advanced Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	simmitinib plus irinotecan liposome	simmitinib plus irinotecan liposome 70 mg/m\^2 every 2 weeks
DRUG	irinotecan liposome	irinotecan liposome 70 mg/m\^2 every 2 weeks
DRUG	irinotecan	irinotecan 180mg/m\^2 every 2 weeks

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: China