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.
Subjects participate voluntarily and sign informed consent.
18-75 years, male or female.
Histologically confirmed Unresectable Advanced or metastatic Esophageal Squamous Cell Carcinomas
No previous systemic anti-tumor treatment for unresectable locally advanced or metastatic esophageal squamous cell carcinoma has been received
Have received anti-PD-1 or anti-PD-L1 antibody therapy;
BMI < 18.5 kg/m2 or weight loss ≥ 10% within 2 months before screening (at the same time, the effect of a large amount of pleural effusions and ascites on bogy weight should be considered);
Presence of any active autoimmune disease or history of autoimmune disease (such as: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose> 10 mg/day prednisone or other equivalent cortiremonial hormones)
Single group
QL1706 plus nab-paclitaxel and cisplatin
DrugQL1706 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.
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
OS
OS is defined as the time from the first administration to death due to any cause
DOR
DOR is defined for participants who demonstrate a confirmed CR or PR, per RECIST 1.1 by the investigators
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.
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