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).
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 Esophageal Squamous Cell Carcinoma (ESCC). Primary Efficacy Endpoint: Disease Free Survival (DFS) (According to RECIST Version 1.1), Secondary Efficacy Endpoints:1-year DFS rate, 3-year DFS rate, 1-year Overall Survival (OS) rate, 3-year OS rate, and Safety. Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.
TQB2450 is an injection in the form of 600 mg; 1200 mg, iv, D1.
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
RECRUITINGDFS
Disease Free Survival
Time frame: DFS was defined as the time from the day patients received first dose of treatment regimen until the date of first documented recurrence or death from any cause, whichever come first, assessed up to 96 months.
1-year DFS rate
One year Disease Free Survival rate
Time frame: 1-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for one year.
3-year DFS rate
Three year Disease Free Survival rate
Time frame: 3-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for 3 years.
1-year OS rate
One year Overall Survival rate
Time frame: 1-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for one year.
3-year OS rate
Three year Overall Survival rate
Time frame: 3-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for 3 years.
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