Source: Pharma News Express
On February 19, Qilu Pharmaceutical registered in the Clinical Trial Registration Platform of the Center for Drug Evaluation (CDE) in China.An Evaluation of QL1706 (Epalumab Injection, Trade Name: QibeanA Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of Perioperative Treatment Combined with Neoadjuvant Chemotherapy (Paclitaxel + Carboplatin) for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (CTR20250570)”。The main purposes of the study are: 1. To evaluate the pathological complete response rate (pathology CR, pCR) of perioperative QL1706 combined with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma (Phase II stage); 2. To compare the event-free survival (Event-free survival, EFS) of perioperative QL1706 combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma (Phase III stage).The study is led by Beijing Tumor Hospital (PI: Lin Shen & Kexue Chen) and Sichuan Tumor Hospital (PI: Yongtao Han), with participation from eight other hospitals, planning to recruit 30 patients.QL1706（Aipalolitovorelimab InjectionIt is a bifunctional combination antibody composed of ipalimumab, which targets the human programmed death receptor-1 (PD-1), and tovorimab, which targets the human cytotoxic T-lymphocyte-associated protein-4 (CTLA-4). It can specifically bind to the PD-1 and CTLA-4 receptors, blocking the two immune checkpoint signaling pathways of PD-1 with PD-L1 and CTLA-4 with B7-1/B7-2. At the same time, it relieves the inhibitory effects of these two pathways on T lymphocytes, promoting tumor-specific T-cell immune activation, thereby exerting an anti-tumor effect.
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