An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).
• Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
• ≥ 18 years old.
• ECOG performance status of 0-1
• Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.
• Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.
• Laboratory tests must be met:
• Neutrophils count =/\> 1.5 x 109/L, platelets count =/\> 75 x 109/L, Hb =/\> 90 g/L, WBC =/\> 3 x 109/L.
• total bilirubin =/\< 1.5 x ULN, ALT and AST =/\< 2.5 x ULN.
• Creatinine =/\< 1.5 x ULN.
• APTT, INR, PT =/\< 1.5 x ULN.
• TSH =/\< ULN.
• Myocardial enzymes in the normal range.
• LVEF =/\> 50%.