Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study

Not Applicable

Not yet recruiting

• Conditions: Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Digestive System Neoplasms; Liver Neoplasms

• Registration Number: NCT06794073
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Start: 2025-02-28
• Primary Completion: 2026-07-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Age between 18 and 80 years, no gender restriction.
2. Clinically or pathologically confirmed hepatocellular carcinoma (HCC).
3. CNLC stage IIb-IIIa with tumors deemed unresectable after multidisciplinary discussion.
4. No prior systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma.
5. Presence of an ablation-eligible lesion with imaging-evaluable target tumor(s), with the maximum diameter of the target lesion >5 cm.
6. ECOG performance status (PS) of 0-1 and an expected survival of more than 3 months.

Liver function Child-Pugh score ≤7.

Exclusion Criteria

1. Liver function classified as Child-Pugh grade C.
2. Presence of tumor thrombus in the main portal vein or hepatic vein.
3. Extensive systemic metastases with an expected survival of <3 months.
4. Severe failure of major organs, including liver, kidney, heart, lungs, or brain.
5. Recent esophageal (or gastric fundus) variceal rupture and bleeding within the past month.
6. History of other malignancies.
7. Concurrent use of other antitumor therapies, such as radiotherapy or systemic chemotherapy.
8. Active infection, including:HBV infection with HBV DNA <2000 IU/mL (<10⁴ copies/mL) or reduced by one log after antiviral therapy.HCV infection requiring antiviral treatment per clinical guidelines.HIV infection or biliary system inflammation.
9. History of organ transplantation or hepatic encephalopathy.
10. Uncorrectable coagulation disorders.
11. Refractory massive ascites, pleural effusion, or cachexia.
12. Pregnancy, altered consciousness, or inability to cooperate with treatment.
13. Interval of less than one month since the last local therapy.
14. Any other factors deemed by investigators to contraindicate study participation or significantly impact the patient's involvement in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.