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Neoadjuvant Ivonescimab(AK112) Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Jun 1, 2026 to Jun 3, 2026
    • Eligibility criteria expanded, about 12 words
    • Site details revised
  2. Notable Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  3. Notable Start date: Dec 1, 2025 to Jun 1, 2026v3
  4. Notable Primary endpoint revised
    • Secondary endpoints revised (5)
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. It is recommended that a treatment strategy be employed that integrates surgery with radiotherapy, chemotherapy, or immunotherapy, in order to enhance overall survival by improving local-regional tumor control and addressing microscopic metastases. Clinical research indicates that combining anti-PD-1/L1 and anti-VEGF antibodies enhances anti-tumor effects in esophageal squamous cell carcinoma. Ivonescimab, a humanized bispecific monoclonal antibody targeting PD-1/VEGF. This single-arm, prospective, exploratory study is planned to evaluate the combination of ivonescimab and chemotherapy in neoadjuvant therapy for resectable esophageal squamous cell carcinoma, with the aim of providing new therapeutic options for this condition.
Trial Details
NCT Number NCT07244978
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
(from sponsor)
Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
Related terms Esophageal Squamous Cell Carcinoma
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov