Hepatocellular Carcinoma (HCC)
Conditions
Brief summary
To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
Interventions
DRUGFirst-line Cohort
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
DRUGSecond-line Cohort
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
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First-line Cohort: 1. Confirmed diagnosis of hepatocellular carcinoma (HCC), aged \> 18 years. No prior systemic therapy. 2. Child-Pugh class A/B at baseline. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 4. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST). 5. Adequate organ and bone marrow function. Second-line Cohort: 1. Confirmed diagnosis of HCC, aged \> 18 years. 2. Prior first-line therapy (including targeted therapy or immunotherapy). 3. Child-Pugh class A/B at baseline. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 5. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST). 6. Adequate organ and bone marrow function.
Exclusion criteria
1. Concomitant hepatic encephalopathy. 2. History of any nephrotic syndrome. 3. History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization. 4. Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded). 5. History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization. 6. Main portal vein thrombosis visible on baseline imaging. 7. Pleural or peritoneal effusion requiring clinical intervention. 8. Gastroesophageal varices. 9. Portal vein invasion (VP3 or VP4).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 1 year | 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) |
| OS | 2 years | Time from randomization to death from any cause |
| Adverse Events | 2 years | 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 |
Contacts
Primary ContactJun qi Yi, Doctor
Outcome results
None listed