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A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer
Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma
Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
490
Start Date
2024-02-05
Completion Date
2027-12-30
Last Updated
2024-03-07
Healthy Volunteers
No
Conditions
Interventions
KC1036
KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
Irinotecan
Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
Docetaxel
Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks;
S-1
S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle
Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China