This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with chemotherapy (nab-paclitaxel and cisplatin) as a neoadjuvant therapy for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC). The primary objective of this study is to assess the pathologic complete response (pCR) rate in the target population. A total of 33 patients with histologically or cytologically confirmed resectable locally advanced thoracic ESCC are planned to be enrolled.
The study comprises three sequential phases: a Screening Period, a Treatment Period, and a Follow-up Period. Screening Period: Conducted within a maximum of 21 days from the signing of the Informed Consent Form (ICF) up to the first administration of the study drug. Treatment Period: Includes both the neoadjuvant therapy phase and the subsequent surgical resection. Follow-up Period: Consists of safety follow-up, tumor progression/recurrence follow-up, and overall survival follow-up. Neoadjuvant Regimen and Administration Schedule: Patients will receive 3 cycles of neoadjuvant therapy consisting of retlirafusp alfa combined with nab-paclitaxel and cisplatin. Surgical resection is scheduled to be performed 4 to 6 weeks following the completion of the neoadjuvant therapy. A dosing window of ±3 days is permissible during the study treatment period. Prior to each administration (within 3 days before dosing), subjects must undergo standard safety evaluations, including physical examinations (as needed), laboratory tests, and Eastern Cooperative Oncology Group (ECOG) performance status assessments, to confirm treatment tolerance. Laboratory tests completed during the screening period within the protocol-specified timeframe do not need to be repeated prior to the first dose. Safety assessments will be continuously monitored throughout the study duration to ensure subject safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Administered at a fixed dose of 1800 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles. Retlirafusp alfa must be infused first in the sequence, with an interval of at least 30 minutes before the subsequent administration of nab-paclitaxel.
Administered at a dose of 130 mg/m² via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 3 cycles.
Administered at a dose of 75 mg/m² via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles.
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shaanxi, China
Pathological complete response rate (pCR)
Time frame: Pathological detection after surgery within 1 month
Major pathological response rate (MPR)
Time frame: Pathological detection after surgery within 1 month
Event-free survival (EFS)
Time frame: from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first,assessed up to 36 months)
Overall survival(OS)
Time frame: from randomization to death from any cause,assessed up to 36 months
R0 Resection Rate
Time frame: after surgery within 1 month
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Enrollment
33