A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Drug: First-line CohortDrug: Second-line Cohort
- Registration Number
- NCT07150377
- Lead Sponsor
- The Second Affiliated Hospital of Shandong First Medical University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 41
-
First-line Cohort:
- Confirmed diagnosis of hepatocellular carcinoma (HCC), aged > 18 years. No prior systemic therapy.
- Child-Pugh class A/B at baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- Adequate organ and bone marrow function.
Second-line Cohort:
- Confirmed diagnosis of HCC, aged > 18 years.
- Prior first-line therapy (including targeted therapy or immunotherapy).
- Child-Pugh class A/B at baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- Adequate organ and bone marrow function.
- Concomitant hepatic encephalopathy.
- History of any nephrotic syndrome.
- 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.
- 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).
- History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.
- Main portal vein thrombosis visible on baseline imaging.
- Pleural or peritoneal effusion requiring clinical intervention.
- Gastroesophageal varices.
- Portal vein invasion (VP3 or VP4).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car First-line Cohort - Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car Second-line Cohort -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method OS 2 years Time from randomization to death from any cause
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)
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