A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer

Phase 3

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: KC1036; Drug: Irinotecan; Drug: Docetaxel; Drug: S-1

• Registration Number: NCT06194734
• Lead Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

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/Docetaxe...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Study First Posted: 2024-01-08
• Study Start: 2024-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

• Males or females aged 18 to 75 years;
• Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
• Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemic therapy;
• At least one measurable tumor lesion according to RECIST 1.1;
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• BMI≥16.0 and weight≥40 kg ;
• Adequate bone marrow, renal, and hepatic function;
• Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before randomization；
• Patients should participate in the study voluntarily and sign informed consent.

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Exclusion Criteria

• Any patient who is known to have untreated central nervous system (CNS) metastasis;
• Other kinds of malignancies within 5 years;
• Gastrointestinal abnormalities;
• Cardiovascular and cerebrovascular diseases;
• Prior therapies with vascular targeting inhibitor；
• Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium；
• Involved in other clinical trials within 4 weeks before enrollment；Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
• Uncontrolled massive ascites, pleural or pericardial effusion;
• Severe infection within 4 weeks prior to randomization (CTCAE > Grade 2);
• Known history of human immunodeficiency virus (HIV) infection or current active hepatitis B or C infection;
• Pregnant or lactating women;
• Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
• Other patients are not eligible for enrollment assessed by investigators.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KC1036	KC1036	KC1036 will be administrated.
Investigator's choice of chemotherapy	Irinotecan	Irinotecan, Docetaxel or S-1 will be administrated.
Investigator's choice of chemotherapy	Docetaxel	Irinotecan, Docetaxel or S-1 will be administrated.
Investigator's choice of chemotherapy	S-1	Irinotecan, Docetaxel or S-1 will be administrated.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Baseline to study completion (approximately 24 months)	OS is defined as the time from the start of randomization to death of any cause.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Baseline to study completion (approximately 24 months)	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.
Progression-free survival (PFS)	Baseline to study completion (approximately 24 months)	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.
Duration of Response (DOR)	Baseline to study completion (approximately 24 months)	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.
Quality of Life (QOL) scores	Baseline to study completion (approximately 24 months)	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.
Objective Response Rate (ORR)	Baseline to study completion (approximately 24 months)	ORR is defined as the proportions of patients with a complete response (CR) or partial response (PR) according to RECIST 1.1.
Incidence of Adverse events (AEs)	Baseline to 30 days after the last dose of study treatment	Assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the treatment assessed by NCI CTCAE 5.0.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China