Phase IbII Study of Ivonescimab AK112 with Albumin-Paclitaxel and Cisplatin as Pre-Surgery Treatment for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of Ivonescimab AK112 with albumin-paclitaxel and cisplatin as a neoadjuvant therapy for patients with resectable, locally advanced esophageal squamous cell carcinoma. This prospective, multicenter Phase IbII trial aims to study the treatments safety, dosage, and effectiveness in preparing patients for surgery by reducing tumor size before the operation. Participants receive AK112 intravenously every three weeks, with dosing starting at 10 mgkg in the first cohort and increasing to 20 mgkg in the second. Another group receives AK112 combined with albumin-paclitaxel and carboplatin chemotherapy administered intravenously in cycles of three every three weeks. The study includes a dose escalation phase followed by a treatment phase to assess the best dose and combination. Throughout the study, participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and major pathologic response for up to two years. Other evaluations include tumor response, event-free survival, and overall survival. Safety monitoring continues for 90 days after the last dose, with participants expected to comply with scheduled visits, treatments, laboratory tests, and study procedures over the study duration.

A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC