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

March 6, 2024 updated by: Beijing Konruns Pharmaceutical Co., Ltd.

A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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/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

Enrollment (Estimated)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KC1036
KC1036 will be administrated.
Drug: KC1036
KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
Active Comparator: Investigator's choice of chemotherapy
Irinotecan, Docetaxel or S-1 will be administrated.
Drug: Irinotecan
Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
Drug: Docetaxel
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
Other Names:
  • Tegafur-gimeracil-oteracil potassium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Baseline to study completion (approximately 24 months)
OS is defined as the time from the start of randomization to death of any cause.
Baseline to study completion (approximately 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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.
Baseline to study completion (approximately 24 months)
Disease Control Rate (DCR)
Time Frame: 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.
Baseline to study completion (approximately 24 months)
Duration of Response (DOR)
Time Frame: 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.
Baseline to study completion (approximately 24 months)
Progression-free survival (PFS)
Time Frame: 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.
Baseline to study completion (approximately 24 months)
Incidence of Adverse events (AEs)
Time Frame: 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.
Baseline to 30 days after the last dose of study treatment
Quality of Life (QOL) scores
Time Frame: 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.
Baseline to study completion (approximately 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Konruns Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jing Huang, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC1036-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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