Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
Recruiting
Phase 2Interventional Study
HCC
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
29 (estimated)
Sponsor
Tianjin Medical University Cancer Institute and Hospital · Other
Who this trial is looking for
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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.
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Status
Eligibility Criteria
Inclusion 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;
* ECO…
Inclusion 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.Exclusion Criteria:
* 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.
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