Adenocarcinoma, Carcinoma, Hepatocellular, Digestive System Neoplasms, Liver Neoplasms, Neoplasms, Glandular and Epithelial
Conditions
Keywords
Multimodal, Tislelizumab, lenvatinib, TACE, unresectable primary liver cancer
Brief summary
This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.
Detailed description
This study aims to evaluate the efficacy and safety of multimodal ablation combined with Tislelizumab, lenvatinib, and TACE in the treatment of primary liver cancer. By comparing preoperative and postoperative immune markers, the study seeks to clarify the clinical value of multimodal ablation combined with systemic therapy and TACE in the management of primary liver cancer.
Interventions
The high-burden tumor is identified as the target lesion for treatment. A pre-treatment biopsy of the target lesion is performed to obtain tumor tissue. Multimodal ablation therapy of the target lesion is conducted under CT guidance. The treatment procedure follows the tumor ablation protocol using the multimodal therapy radiofrequency temperature-controlled mode.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years, regardless of gender. 2. Clinically or pathologically confirmed HCC. 3. CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation. 4. Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \>5 cm. 5. Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment.. 6. ECOG PS 0-1 and an expected survival \>3 months. 7. Child-Pugh score ≤7.
Exclusion criteria
1. Child-Pugh class C liver dysfunction. 2. Tumor thrombus in the main portal vein or hepatic vein. 3. Extensive metastatic disease with an expected survival \<3 months. 4. Severe dysfunction of major organs (liver, kidney, heart, lung, or brain). 5. History of esophageal/gastric variceal bleeding within the past month. 6. History of other malignancies. 7. Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \<1 month. 8. Active infection; HBV co-infection (HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation. 9. History of organ transplantation or hepatic encephalopathy. 10. Uncorrectable coagulation disorders. 11. Refractory massive ascites, pleural effusion, or cachexia. 12. Pregnancy, impaired consciousness, or inability to comply with treatment. 13. High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \>12). 14. Any other condition deemed unsuitable by investigators that may affect study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) according to RECIST 1.1 and mRECIST | Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively. | Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using RECIST 1.1 and mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival（PFS） | Follow-up for 12 months,with assessments conducted every 3 months. | It refers to the time from the date of enrollment to the date of the first recorded disease progression(PD)or death,whichever occurs first. |
| Overall Survival（OS） | Follow-up for 12 months,with assessments conducted every 3 months. | Overall Survival(OS)refers to the time from the date of enrollment to the date of death due to any cause. |
| Safety and Tolerability | Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively. | Safety:Refers to the extent to which a drug does not cause unacceptable harm or side effects when applied in the human body.Tolerability:Refers to the degree to which patients accept the side effects that occur after treatment,reflecting their ability to endure the side effects of the medication.All adverse events will be recorded and assessed for severity based on the NCI-CTC AE 5.0 grading criteria.During the follow-up period,all subjects will be continuously monitored,and the occurrence,duration,severity,and treatment-relatedness of adverse events will be documented. |
Countries
China
Contacts
CONTACTzhiping Yan, M.D
Outcome results
None listed