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
This is a randomized, controlled, open-label, multicenter phase III trial. Patients with advanced recurrent or metastatic esophageal squamous cell carcinoma that has received PD-1 or PD-L1 inhibitors and at least second-line systemic therapy will be randomized at a 1: 1 ratio to receive KC1036 or the investigator's choice of chemotherapy (Irinotecan/Docetaxel/S-1) until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
490
KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks；
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGOverall survival (OS)
OS is defined as the time from the start of randomization to death of any cause.
Time frame: Baseline to study completion (approximately 24 months)
Objective Response Rate (ORR)
ORR is defined as the proportions of patients with a complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: Baseline to study completion (approximately 24 months)
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Time frame: Baseline to study completion (approximately 24 months)
Duration of Response (DOR)
DOR is defined as the time from first documented objective response (complete response (CR)or partial response (PR)) to the date of first documented disease progression (PD) or death.
Time frame: Baseline to study completion (approximately 24 months)
Progression-free survival (PFS)
PFS is defined as the time from the start of randomization to the date of the first documented progressive disease (PD) according to RECIST 1.1 or death.
Time frame: Baseline to study completion (approximately 24 months)
Incidence of Adverse events (AEs)
Assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the treatment assessed by NCI CTCAE 5.0.
Time frame: Baseline to 30 days after the last dose of study treatment
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S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle
Quality of Life (QOL) scores
Quality of Life is a concept of comprehensive evaluation of the advantages and disadvantages of life. It mainly refers to the assessment of individual physiological, psychological and social functions, which is an important indicator of the effectiveness of medical and health care services.
Time frame: Baseline to study completion (approximately 24 months)