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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: HS-20093 for injection
|
The patient will receive treatment with HS-20093.
Andra namn:
|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival (OS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Förekomst och svårighetsgrad av biverkningar
Tidsram: Från första dosen tills 90 dagar efter sista dosen
|
Från första dosen tills 90 dagar efter sista dosen
|
|
|
Förekomst och svårighetsgrad av SAE
Tidsram: Från första dosen till 90 dagar efter sista dosen
|
Från första dosen till 90 dagar efter sista dosen
|
|
|
Progression-free survival (PFS) assessed by investigator
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Neoplasmer, körtel och epitel
- Neoplastiska processer
- Esofagussjukdomar
- Carcinom
- Neoplasmer, skivepitelceller
- Karcinom, skivepitel
- Esofagusneoplasmer
- Patologiska tillstånd, tecken och symtom
- Esofagus skivepitelcancer
- Neoplasma Metastas
- Organiska kemikalier
- Heterocykliska föreningar
- Terapeutik
- Drogadministrationsvägar
- Narkotikabehandling
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Camptotecin
- Alkaloider
- Taxoids
- Cyklodekaner
- Gentare
- Docetaxel
- Irinotekan
- Paklitaxel
- Injektion
Andra studie-ID-nummer
- HS-20093-310
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .