This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months. The main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events 1. Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W; 2. Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W; 3. Cisplatin: 75 mg/m², d1, Q3W;
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
RECRUITINGObjective response rate(ORR)
The objective response rate (ORR) evaluated by investigator based on RECIST 1.1
Time frame: 18months
Progression-free survival (PFS)
The Progression-free survival (PFS) evaluated by investigator based on RECIST 1.1
Time frame: 24months
Disease control rate (DCR)
Disease control rate (DCR) evaluated by investigator based on RECIST 1.1
Time frame: 18months
Duration of response (DoR)
Duration of response (DoR) evaluated by investigator based on RECIST 1.1
Time frame: 24months
Overall survival(OS)
Overall survival(OS)
Time frame: 30months
Adverse events(AEs)
The incidence and severity of adverse events (AEs) : The incidence and severity of adverse events (AE) and serious adverse events (SAE) were determined based on the NCI-CTCAE v5.0 standard. Abnormal vital signs and laboratory tests, etc
Time frame: 24months
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