Hepatocellular carcinoma
Conditions
Interventions
Experimental group:lparomlimab and Tuvonralimab Injection +TACE + Lenvatinib
Sponsors
Tianjin Cancer Hospital Airport Hospita
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Comprehension and voluntary signing of the informed consent form; 2.Age >=18 years, any gender; 3.Histopathologically or cytologically confirmed hepatocellular carcinoma (HCC); 4.Failure or intolerance to first-line PD-1/PD-L1 inhibitor combined with bevacizumab therapy; 5.ECOG performance status 0-2; 6.Child-Pugh class A or class B (score =3 months; 8.At least one measurable target lesion confirmed by imaging per RECIST v1.1 during screening; 9.Adequate organ and bone marrow function within 7 days prior to first study drug administration; 10.If HBV/HCV infection present, must receive ongoing antiviral therapy with documented viral suppression; 11.Fertile patients must agree to use highly effective contraception by both partners during treatment and for>=180 days after last dose.
Exclusion criteria
Exclusion criteria: 1.Inability to comply with the study protocol or procedures. 2.Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma. 3.History of liver transplantation or planned liver transplantation. 4.Patients with evidence of central nervous system metastasis and/or carcinomatous meningitis. 5.Presence of Vp4 portal vein thrombosis confirmed by baseline imaging. 6.Hypersensitivity to the investigational drug or any of its excipients, or a history of hypersensitivity reactions. 7.Coinfection with hepatitis B virus (HBV) and hepatitis C virus (HCV). 8.Ascites requiring clinical intervention identified during screening examinations. 9.Concurrent use of any other investigational drug, or participation in another clinical trial involving investigational drug therapy within 4 weeks prior to enrollment. 10.History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first dose, or presence of high-grade varices confirmed by endoscopy within 3 months prior to the first dose. 11.Current interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia/interstitial lung disease requiring glucocorticoid therapy; or other pulmonary conditions (e.g., pulmonary fibrosis, organizing pneumonia) that may interfere with the assessment and management of immune-mediated pulmonary toxicity. 12.Concurrent occurrence of any of the following: (1) Uncontrolled hypertension, coronary artery disease, arrhythmias, or heart failure; (2) Uncontrolled severe concurrent infections; (3) Proteinuria >=2+ (>=1.0 g/24 hours); (4) Evidence or history of hemorrhagic tendency within 2 months before enrollment, regardless of severity; (5) Arterial/venous thromboembolic events (e.g., cerebrovascular accident, including transient ischemic attack) within 12 months before initial treatment; (6) Acute myocardial infarction, acute coronary syndrome, or coronary artery bypass grafting (CABG) within 6 months before initial treatment; (7) Unhealed fractures or chronic non-healing wounds; (8) Coagulopathy, hemorrhagic tendency, or ongoing anticoagulation therapy. 13.History of other malignancies within 5 years prior to enrollment, excepting radically resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix. 14.Active autoimmune disease or documented history of autoimmune disease within 4 weeks prior to enrollment. 15.Prior allogeneic bone marrow transplantation or solid organ transplantation. 16.Patients deemed by the Investigator to be unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR);Overall Survival (OS);Disease Control Rate (DCR);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactTongguo Si
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed