Hepatocellular carcinoma
Conditions
Interventions
Test group:Recombinant Human Adenovirus Type 5 (H101) Injection Combined with Transarterial Chemoembolization (TACE) Sequentially Administered with PD-1 Inhibito
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participates in this study and has signed the informed consent form; 2. Age 18–75 years, male or female; 3. According to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer in China (2024 Edition), patients meet the criteria for China Liver Cancer Staging (CNLC) stage IIa, IIb, or IIIa, or Barcelona Clinic Liver Cancer (BCLC) stage B or C, and are not candidates for radical treatment such as surgical resection, liver transplantation, or ablation. Patients with CNLC stage Ib or BCLC stage A who are judged by the investigator (in combination with relevant clinical guidelines) to be ineligible for radical treatment may also meet the inclusion criteria; 4. Eligible for the predefined TACE procedure and chemotherapeutic agents at the study center, with no contraindications; 5. At least 1 measurable target lesion according to the mRECIST criteria (based on imaging findings at screening); 6. Child-Pugh liver function grade: = 3 months; 9. Tumor burden = 3×10^9/L; platelet (PLT) count >= 50×10^9/L (without transfusion or colony-stimulating factor support). (2) Liver function: serum total bilirubin (TBIL) = 30 g/L. (3) Renal function: serum creatinine (Cr) = 30 mL/min, calculated by the Cockcroft-Gault formula: Male: CCr = ((140 - Age) × Body weight) / (72 × Serum Cr) Female: CCr = ((140 - Age) × Body weight) / (72 × Serum Cr) × 0.85 Body weight in kg; serum Cr in mg/mL. 11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must not be breastfeeding. Both women and men of childbearing potential must agree to use highly effective contraception from signing informed consent, during the study, and for 6 months after study completion; men must refrain from sperm donation during this period; 12. Good subject compliance and willingness to comply with follow-up procedures;
Exclusion criteria
Exclusion criteria: 1. Imaging indicates the presence of extrahepatic metastatic lesions (including regional lymph node metastasis); 2. Diffuse HCC or tumors not suitable for evaluation by mRECIST criteria; 3. Presence of Vp3 or Vp4 vascular invasion, tumor thrombus in the hepatic vein or inferior vena cava, or tumor thrombus involving the superior mesenteric vein or more distal sites; 4. Concurrent with other malignancies; 5. Previous treatment with oncolytic viral agents (e.g., T-VEC); 6. Previous systemic or local therapy for HCC, including chemotherapy, molecular targeted therapy, immunotherapy, interventional therapy, TACE, radiotherapy, etc; 7. Hepatic artery malformation that prevents catheterization; 8. Hypersensitivity to the study drug or its active ingredients, or history of allergy to similar biological agents; 9. Clinical manifestations of decompensated liver cirrhosis (e.g., hepatic encephalopathy); 10. Moderate or higher grade esophagogastric varices; 11. Severe pulmonary insufficiency (forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] 2×10^3 IU/mL; 17. Positive hepatitis C virus (HCV) antibody; 18. History of psychiatric disorders, drug abuse, or narcotic use; 19. Pregnant or lactating females; 20. Other factors deemed inappropriate by the investigator for participation in this study, e.g., the investigator judges that participation is not in the best interest of the subject;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progress; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Time to progress;Biomarker parameters;Severe adverse event;Quality of Life of Patients;Adverse event;Conversion rate;Duration of response;Localized Time to progress;Overall survival; | — |
Countries
China
Contacts
Public ContactChen Zhiyu
The First Affiliated Hospital of Army Medical University
Outcome results
None listed