Actively Recruiting
Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-08-29
29
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically or clinically confirmed hepatocellular carcinoma
- Documented failure or intolerance to first-line therapy with PD-1/PD-L1 inhibitor plus bevacizumab
- ECOG performance status of 0 to 2
- Child-Pugh class A or B (score 7 or less) without history of hepatic encephalopathy
- Life expectancy of at least 3 months
- At least one measurable target lesion confirmed by screening imaging per RECIST v1.1
- Adequate organ and bone marrow function within 7 days prior to initial study treatment
- Active HBV or HCV infection requires ongoing antiviral therapy
- Fertile patients must use highly effective contraception with partners during treatment and for at least 180 days after last dose
You will not qualify if you...
- Inability to comply with the study protocol or procedures
- Fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma
- History of liver transplantation or planned liver transplantation
- Presence of central nervous system metastases or leptomeningeal carcinomatosis
- Baseline imaging showing Vp4 portal vein tumor thrombosis
- Hypersensitivity to any study drug components or history of severe allergic reactions
- Concurrent HBV and HCV co-infection
- Clinically significant ascites requiring intervention during screening
- Participation in another clinical trial or use of other investigational drugs within 4 weeks prior to enrollment
- Esophageal or gastric variceal bleeding due to portal hypertension within 6 months or high-risk varices on endoscopy within 3 months
- Current interstitial lung disease, history of steroid-required ILD, or other pulmonary fibrosis/organizing pneumonia
- Uncontrolled hypertension, coronary artery disease, arrhythmias, or heart failure (NYHA Class II or higher)
- Uncontrolled infections requiring intravenous antimicrobial therapy
- Proteinuria of 2+ or higher (1.0g/24h)
- History of hemorrhagic tendency within 2 months prior to enrollment
- Arterial or venous thromboembolic events within 12 months before treatment
- Acute myocardial infarction, acute coronary syndrome, or coronary artery bypass graft within 6 months before treatment
- Unhealed fractures or chronic non-healing wounds
- Coagulopathy, bleeding diathesis, or current therapeutic anticoagulation
- Other malignancies within 5 years except certain skin or cervical carcinomas
- Active autoimmune disease or history requiring immunosuppression within 4 weeks prior to enrollment
- Prior allogeneic bone marrow or solid organ transplantation
- Investigator assessment of ineligibility based on medical or safety reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
T
Tongguo Si, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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