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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

signed informed consent;

patients age 18 to 75 years old

primary resectable, histologically confirmed esophageal squamous cell cancer;

Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).

Disqualifiers

with significant cardiovascular disease;

current treatment with anti-viral therapy or HBV;

Female patients who are pregnant or lactating;

history of malignancy within 5 years prior to screening;

Trial design

Treatments tested in this trial

  • Ivonescimab(AK112), Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy
  • Esophagectomy
  • Sample

Treatment groups

49 Participants
are divided into 1 treatment group