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.
Single group
Becotatug Vedotin Combined with Cisplatin and Concurrent Radiotherapy
Drug* Becotatug Vedotin：1.5mg/kg 、2.0mg/kg、2.3mg/kg，d1;IV; Q3W * Cisplatin：75mg/m2，d1;IV; Q3W * Radiotherapy：50.4Gy/28f/1.8Gy
Maximum Tolerated Dose (MTD)
MTD is defined as the highest dose level at which DLT is observed in ≤ 1/6 subjects at one single dose group
Recommended Phase 2 Dose (RP2D)
RP2D will be a dose either below or equal to MTD
Dose Limiting Toxicity (DLT)
DLT will be evaluated according to NCI-CTCAE V5.0 criteria
Objective response rate（ORR）
Objective response rate (ORR) is the proportion of subjects with the best overall response being CR or PR (assessed by investigator per RECIST v1.1)
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to RECIST 1.1 criteria, among the total number of evaluable patients.
Progression free survival (PFS)
Progression-Free Survival (PFS) is defined as the time from randomization (or first dose of study treatment) to the first documented disease progression per RECIST 1.1 criteria, or death from any cause, whichever occurs first.
2-year overall survival (OS) rate
The 2-year overall survival (OS) rate is defined as the percentage of patients who remain alive at 2 years after the start of study treatment.
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