Study of Ivonescimab AK112 Combined With Chemotherapy as First Treatment for Advanced Esophageal Squamous Cell Carcinoma in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Ivonescimab AK112 combined with chemotherapy as a first-line treatment for patients with advanced esophageal squamous cell carcinoma ESCC who have not previously received systemic treatment. This phase 2, single-arm study aims to observe treatment responses and tolerability in this patient group, with the study conducted in two stages to monitor initial safety and expand enrollment based on results. In the initial safety phase, 6 patients receive AK112 20 mgkg intravenously every three weeks along with albumin paclitaxel 220 mgm2 and cisplatin 75 mgm2 on the same schedule. Chemotherapy is limited to six cycles, while AK112 treatment may continue for up to 24 months. After safety evaluation, up to 30 additional patients will be enrolled in an expansion phase to further assess efficacy and safety, with potential dose adjustments based on early findings. Participants will undergo regular assessments including imaging every 6 weeks to evaluate tumor response. The primary measure is the objective response rate at 6 months, while secondary outcomes include overall survival at 24 months, progression-free survival at 12 months, disease control rate, and duration of response at 6 months. Safety observations and laboratory tests are conducted throughout treatment, with adherence to scheduled visits and study procedures required. The total duration of participation varies depending on treatment continuation and follow-up.

AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients