A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
- Minimum life expectancy >12 weeks.
- Adequate organ function.
- Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
- Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.
Exclusion Criteria:
1. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:
- 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.
5. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation/fistula, hemorrhage, or obstruction.
9. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
10. Known to have allergic reactions or contraindications to the investigational medicinal product.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: HS-20093 for injection
|
The patient will receive treatment with HS-20093.
Andere namen:
|
|
Actieve vergelijker: Investigator's choice of monochemotherapy
Investigator should choose one of the monochemotherapy (irinotecan, paclitaxel, or docetaxel)
|
The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall survival (OS)
Tijdsspanne: Approximately 4 years after the first patient with first dose
|
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause
|
Approximately 4 years after the first patient with first dose
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidentie en ernst van ongewenste voorvallen
Tijdsspanne: Vanaf de eerste dosis tot 90 dagen na de laatste dosis
|
Vanaf de eerste dosis tot 90 dagen na de laatste dosis
|
|
|
Incidentie en ernst van SAE's
Tijdsspanne: Vanaf de eerste dosis tot 90 dagen na de laatste dosis
|
Vanaf de eerste dosis tot 90 dagen na de laatste dosis
|
|
|
Progression-free survival (PFS) assessed by investigator
Tijdsspanne: Approximately 3 years after the first patient with first dose
|
PFS assessed by investigator per RECIST v1.1
|
Approximately 3 years after the first patient with first dose
|
|
Objective response rate (ORR)
Tijdsspanne: Approximately 2 years after the first patient with first dose
|
ORR assessed by investigator per RECIST v1.1
|
Approximately 2 years after the first patient with first dose
|
|
Disease control rate (DCR)
Tijdsspanne: Approximately 2 years after the first patient with first dose
|
DCR assessed by investigator per RECIST v1.1
|
Approximately 2 years after the first patient with first dose
|
|
Duration of response (DoR)
Tijdsspanne: Approximately 3 years after the first patient with first dose
|
DoR assessed by investigator per RECIST v1.1
|
Approximately 3 years after the first patient with first dose
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Hoofd- en nekneoplasmata
- Neoplasmata, glandulair en epitheel
- Neoplastische processen
- Slokdarmaandoeningen
- Carcinoom
- Neoplasmata, plaveiselcel
- Carcinoom, plaveiselcel
- Slokdarmneoplasmata
- Pathologische aandoeningen, tekenen en symptomen
- Slokdarm plaveiselcelcarcinoom
- Neoplasma metastase
- Organische chemicaliën
- Heterocyclische verbindingen
- Therapeutica
- Routes voor het toedienen van geneesmiddelen
- Drugstherapie
- Koolwaterstoffen
- Cycloparaffins
- Koolwaterstoffen, alicyclisch
- Koolwaterstoffen, cyclisch
- Terpenen
- Camptothecin
- Alkaloïden
- Taxoids
- Cyclodecanes
- Diterpenen
- Docetaxel
- Irinotecan
- Paclitaxel
- Injecties
Andere studie-ID-nummers
- HS-20093-310
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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