The purpose of this study is to assess the efficacy and safety of QL1706 combined with nab-paclitaxel and cisplatin in first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma. QL1706 is a anti-PD-1 and anti-CTLA4 antibody.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
QL1706 will be administrated at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administrated up to 2 year. Nab-paclitaxel will be administrated at a dose of 125mg/m2 intravenously (IV), d1,d8, every 3 weeks for 6 cycles at most. Cisplatin will be administrated at a dose of 75mg/m2 intravenously (IV), every 3 weeks for 6 cycles at most.
ORR
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
Time frame: From the date of first dose to achieving complete response or partial response, assessed up to 42 months
PFS
PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first
Time frame: From the date of first dose to the date of first documented progression or death from any cause, whichever occurs first, assessed up to 42 months.
OS
OS is defined as the time from the first administration to death due to any cause
Time frame: From the date of first dose to the date of death due to any cause, assessed up to 48months.
DOR
DOR is defined for participants who demonstrate a confirmed CR or PR, per RECIST 1.1 by the investigators
Time frame: From the date of first documented evidence of CR or PR to the date of PD or death, assessed up to 42 months.
number of participants with AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: From first dose to the later of 90 days after the last dose of QL1706 or 30 days after the last dose of nab-paclitaxel or cisplatin, assessed up to 48 months.
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