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To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First-line Cohort | Drug | Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Time from randomization to death from any cause | 2 years |
| Objective Response Rate | It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR) |
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Inclusion Criteria:
First-line Cohort:
Second-line Cohort:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun qi Yi, Doctor | Contact | 18265384981 | yiqijun1983@163.com |
| Name | Affiliation | Role |
|---|---|---|
| yan hai Liu | The Second Affiliated Hospital of Shandong First Medical University | Principal Investigator |
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| Second-line Cohort | Drug | Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd |
|
| 1 year |
| Adverse Events | It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug | 2 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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