This study is a single-arm, exploratory clinical trial aimed at evaluating the efficacy and safety of SHR-1701 in combination with liposomal irinotecan (II) in patients with esophageal squamous cell carcinoma who have received prior immunotherapy. Eligible patients with esophageal cancer will be treated with SHR-1701 in combination with liposomal irinotecan (II).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
SHR-1701 in combination with Irinotecan Liposome (II) is administered on Day 1 of each 3-week treatment cycle until disease progression, intolerable toxicity, withdrawal of consent, or a decision by the investigator to discontinue treatment, or until the maximum treatment duration of 2 years has been reached, whichever occurs first.
Shanghai Chest Hospital
Shanghai, China
Objective Response Rate
Objective response rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR).
Time frame: through study completion, an average of 12 weeks
Disease Control Rate
Disease Control Rate (DCR) defined as the proportion of patients whose best overall response is CR, PR, or SD.
Time frame: through study completion, an average of 12 weeks
Progression-Free Survival
Progression-Free Survival defined as the time from the first dose to the first documented disease progression as assessed by the investigator per RECIST version 1.1, or the time from enrollment to death from any cause, whichever occurs first.
Time frame: through study completion, an average of 6 months
Oearall survival
Overall Survival (OS) Defined as the time from the first dose to death from any cause.
Time frame: through study completion, an average of 12 months
Safty
Adverse Events (AEs): Incidence and severity (including whether they are serious adverse events or immune-related adverse events), with severity graded according to NCI-CTCAE version 6.0;
Time frame: Documented from the time of signing the informed consent form until the end of the safety follow-up period (Day 90 after the last dose) or the initiation of a new anti-cancer therapy, whichever occurs first.
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