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

Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.
Study ID
NCT06194734
Phase
PHASE3
Status
Recruiting
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Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Feb 5, 2024
Status verified
Mar 2024
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
490 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KC1036
    KC1036 will be administrated.
  • Active Comparator: Investigator's choice of chemotherapy
    Irinotecan, Docetaxel or S-1 will be administrated.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Baseline to study completion (approximately 24 months) ]

Central Contacts

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