A Phase 3 interventional study of KC1036 and Irinotecan in Esophageal Squamous Cell Carcinoma, sponsored by Beijing Konruns Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Beijing Konruns Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 490 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Beijing Konruns Pharmaceutical Co., Ltd. is the lead sponsor of 13 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
KC1036 will be administrated.
Drug: KC1036
Irinotecan, Docetaxel or S-1 will be administrated.
Drug: Irinotecan · Drug: Docetaxel · Drug: S-1
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；
S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle
Also known as: Tegafur-gimeracil-oteracil potassium
Overall 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
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)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Konruns Pharmaceutical Co., Ltd.