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New treatment option for HCC
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
ClinicalTrials.gov ID: NCT07099274
What this study is testing
What is lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib?
lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hcc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Comprehension and voluntary signing of the study's informed consent form;
- Age ≥18 years, 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 0-2;
You likely can't join if
- Inability to comply with the study protocol or procedures;
- Histologically/cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma;
- History of liver transplantation or planned transplantation;
- Presence of central nervous system metastases and/or leptomeningeal carcinomatosis;
- Baseline imaging showing Vp4 portal vein tumor thrombosis;
- Hypersensitivity to any study drug components or history of severe allergic reactions;
See the full eligibility criteria
- Comprehension and voluntary signing of the study's informed consent form;
- Age ≥18 years, 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 0-2;
- Child-Pugh class A or class B (score ≤7) without hepatic encephalopathy history;
- Life expectancy ≥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/HCV infection requires ongoing antiviral therapy; k.Fertile patients must use highly effective contraception with partners during treatment and ≥180 days post-last dose. 2.
- Inability to comply with the study protocol or procedures;
- Histologically/cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma;
- History of liver transplantation or planned transplantation;
- Presence of central nervous system metastases and/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;
- Concurrent use of other investigational drugs or participation in another clinical trial within 4 weeks prior to enrollment;
- Esophageal/gastric variceal bleeding due to portal hypertension within 6 months before treatment initiation, or high-risk varices on endoscopy within 3 months;
- Current interstitial lung disease (ILD), history of steroid-required ILD, or other pulmonary fibrosis/organizing pneumonia affecting immune-related pulmonary toxicity assessment;
- Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg despite medication), coronary artery disease, arrhythmias, or heart failure (NYHA Class ≥II);
- Uncontrolled clinically significant infections requiring IV antimicrobial therapy;
- Proteinuria ≥2+ (≥1.0g/24h);
- History of hemorrhagic tendency regardless of severity within 2 months prior to enrollment;
- Arterial/venous thromboembolic events within 12 months before treatment initiation (e.g., cerebrovascular accident including TIA);
- Acute myocardial infarction, acute coronary syndrome, or CABG 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 curatively resected basal/squamous cell skin carcinoma or cervical carcinoma in situ;
- Active autoimmune disease or autoimmune disease history requiring immunosuppression within 4 weeks prior to enrollment;
- Prior allogeneic bone marrow or solid organ transplantation;
- Investigator assessment of ineligibility based on medical/safety reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.