This study is an open-label, multi-center phase II clinical trial aimed to evaluat the safety and preliminary efficacy of JS212 combination therapy in patients with advanced esophageal squamous cell carcinoma (ESCC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGdose-limiting toxicity (DLT)
Abnormal changes in laboratory and other tests with clinical significance
Time frame: up to 4 years
adverse event(AE)
Abnormal changes in laboratory and other tests with clinical significance
Time frame: up to 4 years
RP3D
Recommended dose for phase III trial
Time frame: up to 4 years
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Time frame: up to 4 years
Progression free survival(PFS)
The time from first dose to Disease progression or death
Time frame: up to 2years
overall survival (OS)
The time from first dose to death from any cause
Time frame: up to 4 years
immunogenicity
Incidence of Anti-Drug Antibody (ADA)
Time frame: up to 2years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.