NCT07621601Not yet recruitingPhase 3
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
Hansoh BioMedical R&D Company0 sites494 target enrollmentStarted: July 31, 2026Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 494
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to
- •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
- •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.;
- •Persistent adverse reactions caused by prior treatment.
- •Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.
- •5. History of other primary malignancies.
- •Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
- •Severe or poorly controlled hypertension and diabetes mellitus.
- •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.
Investigators
Similar Trials
Not yet recruiting
Phase 3
A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic AlterationsNon-Small Cell Lung CancerNCT07464327Hansoh BioMedical R&D Company450
Not yet recruiting
Phase 3
A Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based TreatmentNCT07392060Shanghai Jiatan Pharmatech Co., Ltd440
Recruiting
Phase 3
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung CancerCTRI/2025/02/080765AstraZeneca AB630
Recruiting
Phase 3
A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)Extensive-stage Small-cell Lung CancerNCT07502300Sichuan Baili Pharmaceutical Co., Ltd.562
Recruiting
Phase 3
JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction AdenocarcinomaNCT07584135NingBo Junyan Hongshi Biosciences Co., Ltd600