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

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

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

Treatments tested in this trial

  • KC1036
  • Irinotecan
  • Docetaxel
  • S-1

Treatment groups

490 Participants
are divided into 2 treatment groups