To observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell carcinoma previously Treated With First-line Immunotherapy
How to improve the efficacy of immunotherapy, evaluate the results of immunotherapy more objectively, and overcome immune resistance through reasonable combined treatment methods, so as to maximize the benefit of patients from immunotherapy, is an urgent research direction to be explored. Therefore, this study intends to observe and evaluate the efficacy and safety of camrelizumab combined with chemotherapy or anlotinib in patients with advanced esophageal squamous cell cancer previously Treated With First-line Immunotherapy . It can provide a basis for the treatment of esophageal cancer after immune resistance.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
200mg/dose intravenous infusion, D1, once every 3 weeks (q3w);
100-125mg/m2,d1,d8;q21d
135-175mg/m2,d1,Q3W
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Objective response rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 24 month
Duration of response (DoR)
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 24 month
Disease control rate (DCR)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.
Time frame: Up to 24 month
Progression-free survival (PFS)
Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause
Time frame: Up to 24 month
Overall survival (OS)
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Time frame: Up to 24 month
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100-135mg/m2, d1、d8,Q3W
60-75mg/m2,d1,Q3W
12mg,qd,d1-d14,q3w