This is an open-label, multicenter, phase Ib study to evaluate the safety, tolerability, and preliminary efficacy of AN0025 in combination with chemoradiotherapy (CRT) in patients with locally advanced/locally recurrent esophageal cancer.
This study will enroll patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer to assess the safety and tolerability of AN0025 at 250mg QD and 500mg QD combined with concurrent chemoradiotherapy to fix the MTD or RP2D. At RP2D level, another 20 patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer will be enrolled at PR2D dose level to explore the preliminary efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
250 mg or 500 mg Q.D., oral administration
Jianming Xu
Beijing, Beijing Municipality, China
Number of participants with Dose Limiting Toxicities (DLTs)
DLTs are defined as study drug-related toxicities graded using Common Terminology Criteria for Adverse events of the National Cancer Institute (NCI CTCAE) V5.0 occurring during DLT period (the first 4 weeks of AN0025 administration in combination with dCRT)
Time frame: 4 weeks
Complete response rate (CRR)
The rate of patients with complete response in all tumor evaluable patients
Time frame: 2 years
Objective response rate (ORR)
The rate of patients with complete response and partial response in all tumor evaluable patients
Time frame: 2 years
Disease control rate (DCR)
The rate of patients with complete response, partial response and stable disease in all tumor evaluable patients
Time frame: 2 years
Progression-free survival (PFS)
The duration from the date of 1st dose to imageological progression or death, which earlier
Time frame: 2 years
Overall survival (OS)
The duration from the date of 1st dose to death
Time frame: 2 years
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