A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer
NCT06194734 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 490
Last updated 2024-03-07
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
Conditions
Interventions
- DRUG
-
KC1036
KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
- DRUG
-
Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
- DRUG
-
Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks;
- DRUG
-
S-1
S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle
Sponsors & Collaborators
-
Beijing Konruns Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jing Huang, Ph.D · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-05
- Primary Completion
- 2026-12-30
- Completion
- 2027-12-30
Countries
- China
Study Locations
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