Liver cancer
Conditions
Interventions
Experimental Group:Apatolimab-Tovotulimumab: 5.0 mg/kg, intravenous infusion, once every 21 days, until disease progression or unacceptable toxicity
Lenvatinib: Dose adjusted according to patient body weight. For patients with body weight =60 kg, the recommended daily dose is 12 mg (three 4 mg capsules), once daily.
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent was obtained before any trial-related procedures were performed; 2. Male or female >=18 years old, 3 months; 8. At least one measurable lesion according to RECIST1.1 criteria; 9. All acute toxic effects from previous antineoplastic therapy resolved to grade 0-1 according to the NCI CTCAE, version 5.0, or to an acceptable inclusion/exclusion level; 10. Adequate organ function: WBC>=3.0*10^9/L, PLT>=75*10^9/L, Hgb>=80*10^9/L; ALT=28g/L; CCr>=80ml/min; 11. For women of childbearing age with a negative pregnancy test (urine or blood) (WOCBP) and consent to use an effective method of contraception. Women of reproductive age are those who are biologically capable of becoming pregnant. Continued use of a reliable contraceptive method, beginning with test screening;
Exclusion criteria
Exclusion criteria: 1. Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage; 2. Central nervous system metastasis; 3. Known cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and hepatic fibrolamellar carcinoma; 4. Severe organ dysfunction (heart, liver, kidney); 5. Known hypersensitivity or allergic reaction to any component of the study treatment; 6. Previous history of organ transplantation or autologous/allogeneic stem cell transplantation; 7. Receiving hormonal therapy other than chronic systemic immunotherapy or physiological replacement therapy; 8. Any unstable systemic disease: "Active infection, severe uncontrolled hypertension, unstable angina pectoris, angina pectoris with onset within the last 3 months, congestive failure (New York Heart Association [NYHA] class II or higher), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring medical treatment, gastrointestinal bleeding or a tendency to active bleeding within 1 month;" 9. Combined with other uncured malignant tumors, except carcinoma in situ; 10. Any disease, metabolic disorder, or physical examination or laboratory suspicion that the patient has contraindications to the study drug or high risk factors for treatment complications; 11. Received treatment in another clinical trial or is conducting another clinical study within 4 weeks before the first dose; 12. Pregnancy or lactation; 13. Subjects who are considered by the investigator to have other adverse health conditions or mental states that may affect the protocol compliance and the evaluation of the trial indicators, and are not suitable for participating in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival period;Overall survival period;Disease control rate;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactFengming Yi
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed