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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Fase 3
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HS-20093 for injection
|
The patient will receive treatment with HS-20093.
Andre navn:
|
|
Aktiv komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst og alvorlighetsgrad av bivirkninger
Tidsramme: Fra første dose til 90 dager etter siste dose
|
Fra første dose til 90 dager etter siste dose
|
|
|
Forekomst og alvorlighetsgrad av SAE-er
Tidsramme: Fra første dose til 90 dager etter siste dose
|
Fra første dose til 90 dager etter siste dose
|
|
|
Progression-free survival (PFS) assessed by investigator
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Neoplastiske prosesser
- Esophageal sykdommer
- Karsinom
- Neoplasmer, plateepitelceller
- Karsinom, plateepitel
- Neoplasmer i spiserøret
- Patologiske tilstander, tegn og symptomer
- Esophageal plateepitelkarsinom
- Neoplasma Metastase
- Organiske kjemikalier
- Heterocykliske forbindelser
- Terapeutikk
- Drug Administration -ruter
- Medikamentell terapi
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Camptothecin
- Alkaloider
- Taxoider
- Cyclodecanes
- Diterpenes
- Docetaxel
- Irinotekan
- Paclitaxel
- Injeksjoner
Andre studie-ID-numre
- HS-20093-310
Legemiddel- og utstyrsinformasjon, studiedokumenter
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