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.
Age ≥18 years old, gender not limited;
Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types);
For patients who have previously received adjuvant/neoadjuvant chemotherapy/chemoradiotherapy, or radical concurrent chemoradiotherapy , the time from the last treatment to disease recurrence is more than 6 months;
ECOG 0-1;
Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy;
Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction;
There is a risk of perforation after stent implantation in the esophageal or tracheal cavity;
Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past;
Single group
Iparomlimab and Tuvonralimab combined with chemotherapy
DrugPatients 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;
Objective response rate（ORR）
The objective response rate (ORR) evaluated by investigator based on RECIST 1.1
Progression-free survival （PFS）
The Progression-free survival (PFS) evaluated by investigator based on RECIST 1.1
Disease control rate (DCR)
Disease control rate (DCR) evaluated by investigator based on RECIST 1.1
Duration of response (DoR)
Duration of response (DoR) evaluated by investigator based on RECIST 1.1
Overall survival（OS）
Overall survival（OS）
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