Patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma are recruited to this prospective non-randomized study comprising two separate cohorts. Patients will receive SHR-1210, a novel anti-PD-1 antibody, with apatinib and either irinotecan or paclitaxel liposome plus nedaplatin. The primary endpoint is to determine the objective response rate (ORR) of patients in both cohorts. The regimen(s) of promising efficacy will be further verified in subsequent randomized studies to define the optimal combination of immunotherapy, anti-angiogenesis and chemotherapy in advanced esophageal cancer patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
a novel anti-PD-1 antibody
a VEGFR-2 tyrosine kinase inhibitor
cytotoxic agent that binds to topoisomerase I
cytotoxic agent that prevent depolymerization of cellular microtubules
cytotoxic agent that cross-links and denatures strands of DNA
Jing Huang
Beijing, China
RECRUITINGobjective response rate
objective response rate of the patients in cohort 1 and cohort 2
Time frame: 24 months
progression-free survival (PFS)
progression-free survival (PFS) of the patients in cohort 1 and cohort 2
Time frame: 24 months
overall survival
overall survival of the patients in cohort 1 and cohort 2
Time frame: 24 months
treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 months
Jianping Xu, MD
CONTACT
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