NCT06656091

A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma

Simmitinib Versus Investigator's Choice of Chemotherapy for Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma : a Randomised, Open-label, Multicentre, Phase 3 Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.

Detailed description

This is a randomised, open-label, multicentre, phase 3 study. Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy will be randomly assigned to the experimental group or control group in a 1:1 ratio. The experimental group received treatment with Simmitinib, while the control group received investigator's choice of chemotherapy, include docetaxel or irinotecan.

Conditions

• Advanced Oesophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	simmitinib	simmitinib 6mg,QD ,3 weeks on 1 week off
DRUG	investigator's choice of chemotherapy,include docetaxel or irinotecan.	docetaxel injection 75mg/m\^2,d1,every 3 weeks or ilinotecan injection 180mg/m\^2,d1,every 2 weeks

Timeline

• Start date: 2024-10-31
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2024-10-24
• Last updated: 2024-10-24