Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Keywords
ESCC, HS-20093, advanced, metastatic
Brief summary
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.
Detailed description
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.
Interventions
The patient will receive treatment with HS-20093.
DRUGIrinotecan; Paclitaxel; Docetaxel
The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years at the time of informed consent form (ICF) signature, either sex. 2. 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. 3. Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment. 4. Presence of at least one target lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1. 6. Minimum life expectancy \>12 weeks. 7. Adequate organ function. 8. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis. 9. 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: 1. Prior or current treatment targeting B7-H3; 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) assessed by investigator | Approximately 3 years after the first patient with first dose | PFS assessed by investigator per RECIST v1.1 |
| Objective response rate (ORR) | Approximately 2 years after the first patient with first dose | ORR assessed by investigator per RECIST v1.1 |
| Disease control rate (DCR) | Approximately 2 years after the first patient with first dose | DCR assessed by investigator per RECIST v1.1 |
| Duration of response (DoR) | Approximately 3 years after the first patient with first dose | DoR assessed by investigator per RECIST v1.1 |
| Incidence and severity of AEs | From the first dose until 90 days after the last dose | — |
| Incidence and severity of SAEs | From the first dose until 90 days after the last dose | — |
Outcome results
None listed