This study is a prospective, single-arm, single-center Phase Ib clinical trial of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The primary objectives are to investigate the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended Phase II dose (RP2D) of Becotatug Vedotin in combination with cisplatin and concurrent radiotherapy for locally advanced esophageal squamous cell carcinoma. The secondary objectives are to assess the efficacy and safety of this combination regimen.
Subjects who are able to understand and voluntarily sign informed consent forms (ICFs).
Male and female subjects at the age of ≥18 and ≤75 at the time of screening.
Histologically confirmed esophageal squamous cell carcinoma staged as cT2-T4a, N0-N+, M0-M1 (M1 limited to supraclavicular lymph node metastasis only).
Patients must have at least one measurable lesion as defined by RECIST version 1.1 criteria.
Diagnosis of any other malignancy within the past 5 years (excluding carcinoma in situ, basal cell carcinoma, etc.).
Anyone allergic to any drug or any of its components in this regimen.
Patients with a prior history of surgery for esophageal squamous cell carcinoma.
Patients with a prior history of fistula caused by primary tumor infiltration.