Phase II Study of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection as Postoperative Therapy for Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of Anlotinib Hydrochloride Capsules and TQB2450 Injection as a postoperative adjuvant therapy for patients with esophageal squamous cell carcinoma ESCC. This Phase II, open-label, single-arm study aims to assess the efficacy and safety of this combination treatment, focusing primarily on disease-free survival DFS. The study also looks at one- and three-year DFS and overall survival rates, along with safety outcomes classified by adverse event severity. Participants will receive treatment in 21-day cycles, taking Anlotinib orally at 12 mg daily for the first 14 days, along with a single intravenous dose of 1200 mg TQB2450 on day one of each cycle. If participants experience side effects from Anlotinib, the dose may be reduced to 10 mg or 8 mg. The study treatment continues as determined by the researchers. During the study, participants will be closely monitored through laboratory tests and imaging to detect any cancer recurrence or progression. Researchers will track disease-free survival from the start of treatment up to 96 months, along with overall survival rates at one and three years. Safety will be evaluated by recording and categorizing adverse events. Participants are expected to follow up regularly and comply with study procedures throughout the treatment and observation period.

Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients