Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iparomlimab and Tuvonralimab combined with chemotherapy | Experimental | 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
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab and Tuvonralimab combined with chemotherapy | Drug | 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; |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | The objective response rate (ORR) evaluated by investigator based on RECIST 1.1 | 18months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The Progression-free survival (PFS) evaluated by investigator based on RECIST 1.1 | 24months |
| Disease control rate (DCR) | Disease control rate (DCR) evaluated by investigator based on RECIST 1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengmian Li | Contact | +8613931185237 | shengmianli2013@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Medical University Fourth Hospital | Recruiting | Shijiazhuang | Hebei | 050000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 18months |
| Duration of response (DoR) | Duration of response (DoR) evaluated by investigator based on RECIST 1.1 | 24months |
| Overall survival(OS) | Overall survival(OS) | 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 | 24months |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided