Health TrialsbyHealthPanel

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

ConditionEsophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Konruns Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • KC1036

    Drug

    KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle

  • Irinotecan

    Drug

    Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks

  • Docetaxel

    Drug

    Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks；

  • S-1

    Drug

    S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle

Treatment groups

490 Participants
are divided into 2 treatment groups
Group A: KC1036Experimental treatment 1 intervention
Group B: Investigator's choice of chemotherapyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Konruns Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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