This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy. Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093) or the control arm (investigator's choice of monochemotherapy, including irinotecan, paclitaxel, or docetaxel). Both experimental arm and control arm will receive a treatment cycle of 21 days until disease progression or other treatment discontinuation criteria are met; Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
494
The patient will receive treatment with HS-20093.
The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel
Overall survival (OS)
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause
Time frame: Approximately 4 years after the first patient with first dose
Progression-free survival (PFS) assessed by investigator
PFS assessed by investigator per RECIST v1.1
Time frame: Approximately 3 years after the first patient with first dose
Objective response rate (ORR)
ORR assessed by investigator per RECIST v1.1
Time frame: Approximately 2 years after the first patient with first dose
Disease control rate (DCR)
DCR assessed by investigator per RECIST v1.1
Time frame: Approximately 2 years after the first patient with first dose
Duration of response (DoR)
DoR assessed by investigator per RECIST v1.1
Time frame: Approximately 3 years after the first patient with first dose
Incidence and severity of AEs
Time frame: From the first dose until 90 days after the last dose
Incidence and severity of SAEs
Time frame: From the first dose until 90 days after the last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.