Hepatocellular carcinoma
Conditions
Interventions
Treatment group:Administer epalumiltoveriviril monoclonal antibody treatment
Sponsors
The First Affiliated Hospital of Guilin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signs the written informed consent form and can comply with the visit schedule and relevant procedures specified in the protocol. 2.Aged 18-75 years (inclusive), regardless of gender. 3.ECOG performance status score of 0 or 1. 4.Expected survival time = 12 weeks. 5.Clinical diagnosis of hepatocellular carcinoma (HCC) in accordance with the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)" confirmed by serum AFP, DCP detection and imaging examinations. 6.Liver function classification: Child-Pugh Class A or well-compensated Class B (=7 points). 7.Has at least one radiologically measurable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or immune RECIST (iRECIST) criteria. 8.Patients with advanced HCC who have progressed after prior PD-1 inhibitor treatment for HCC. 9.Not eligible for curative resection as assessed by the investigator. 10.Has adequate organ and bone marrow function, with laboratory test results meeting the following requirements within 7 days before enrollment (no blood components, cytokines, albumin or other corrective drugs are allowed within 14 days before obtaining laboratory tests): (1) Routine blood test: Absolute neutrophil count (ANC) = 1.5×10^9/L; Platelet count (PLT) = 75×10^9/L; Hemoglobin (HGB) = 80g/L. (2) Liver function: Serum total bilirubin (TBIL) = 1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate transferase (AST) = 5×ULN; Serum albumin = 28g/L; Alkaline phosphatase (ALP) = 5×ULN. (3) Renal function: Serum creatinine (Cr) = 1.5×ULN or creatinine clearance rate (CGr) = 45mL/min (Cockcroft-Gault formula); Urine protein < 2+ on urinalysis. (4) Coagulation function: International normalized ratio (INR) = 2, and activated partial thromboplastin time (APTT) = 1.5×ULN. (5) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range are also eligible. (6) Myocardial enzyme spectrum within the normal range (subjects with simple laboratory abnormalities deemed clinically insignificant by the investigator may also be enrolled). 11.For female subjects of childbearing age, a negative urine or serum pregnancy test must be obtained within 7 days before the first administration of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing age females are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. 12.If there is a risk of conception, all subjects (both male and female) must use contraceptive methods with a yearly failure rate of less than 1% throughout the treatment period and until 120 days after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Histology includes fibroplate hepatocellular hepatocellular carcinoma, sarcomatoid hepatocellular hepatocellular carcinoma, cholangiocarcinoma and other components; 2. Previous liver transplantation; 3. No previous PD-1 inhibitor therapy for hepatocellular carcinoma; 4. Not adequately recovered from toxicities and/or complications caused by any intervention (i.e., =450 ms, female >=470 ms); (2) Cardiac insufficiency or color ultrasound examination according to NYHA standards:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-related adverse event;Desease control rate;progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactShuqun Li
The First Affiliated Hospital of Guilin Medical University
Outcome results
None listed