A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC
Phase Ib/II Trial of Atezolizumab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
Sponsor: Tang-Du Hospital
No open prediction endpoints
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Primary Endpoints (CT.gov)
DLT
Time frame: 1 year
Incidence and Severity of Adverse Events
Time frame: 1 year
MTD
Time frame: 1 year
RP2D
Time frame: 1 year
Secondary Endpoints
Objective response rate (ORR) by RECIST v1.1
Event-Free Survival (EFS)
Total survival time (OS)
Eligibility Criteria
Inclusion Criteria: * Informed Consent: Written informed consent must be obtained before any study-related procedures are initiated. * Age and Gender: Participants must be between 18 and 75 years of age, inclusive of both 18 and 75 years, and may be either male or female. * Diagnosis and Stage: Participants must be histologically confirmed to have resectable, locally advanced esophageal squamous cell carcinoma (ESCC) with the following criteria:-T1 N1-N3 M0 or T2-T4a N0-N3 M0 (with T2 ≥ 2 cm or poorly differentiated). * Lymph Node Status: No suspicious lymph nodes in the neck region (excluding lymph nodes in the upper thoracic esophageal area) as per neck ultrasound or enhanced CT scan; no evidence of systemic metastasis on imaging. * R0 Resectability: The participant is expected to achieve R0 resection. * Measurable Lesion: At least one measurable tumor lesion must be present. * Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected Sur…
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