Status:
NOT_YET_RECRUITING
A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma
Lead Sponsor:
The Second Affiliated Hospital of Shandong First Medical University
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
August 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 24 2028
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT07150377
Start Date
August 24 2025
End Date
August 24 2028
Last Update
September 2 2025
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