A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.
Presence of at least one target lesion according to RECIST v1.1.
Disqualifiers
Prior or current treatment targeting B7-H3;
Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.
Trial design
Design model
Parallel
Treatments tested in this trial
HS-20093 for Injection
DrugThe patient will receive treatment with HS-20093.
Irinotecan; Paclitaxel; Docetaxel
DrugThe patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel
Treatment groups
494 Participants
are divided into 2 treatment groupsGroup A: HS-20093 for injectionExperimental treatment 1 intervention
Group B: Investigator's choice of monochemotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 doseSecondary outcomes
1
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 dose2
Objective response rate (ORR)
ORR assessed by investigator per RECIST v1.1
Time frame
Approximately 2 years after the first patient with first dose3
Disease control rate (DCR)
DCR assessed by investigator per RECIST v1.1
Time frame
Approximately 2 years after the first patient with first dose4
Duration of response (DoR)
DoR assessed by investigator per RECIST v1.1
Time frame
Approximately 3 years after the first patient with first doseLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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