An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
SHR-9839(sc) for Injection,dose level 1
Safety run-in Stage: SHR-9839(sc) for Injection ,dose level 1 or lower dose、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion; Dose extension Stage: SHR-9839(sc) for Injection,dose according to Safety run-in Stage、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion or Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGORR:Objective Response Rate
Time frame: First administration to end of treatment visit about 1year
DOR:Duration of relief
Time frame: First administration to disease progression about 1 year
DCR:Disease Control Rate
Time frame: First administration to disease progression about 1 year
PFS:progression-free survival
Time frame: First administration to disease progression about 1 year
OS:Overall Survival
Time frame: First administration until participant's death about 2 years
DLT:The Dose-Limiting Toxicity
Time frame: Post-dose at day 1 to Day21
MTD: The Maximum Tolerated Dose
Time frame: Post-dose at day 1 to Day21
AE:Incidence and severity of adverse events
Time frame: Sign the informed consent form until Safety follow-up completed about 1 year
ADA :Anti-Drug Antibody
Time frame: Day1 pre-dose to 30 days after the last dose about 1 year
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