Clinical trial NCT06794073: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Adenocarcinoma
Digestive System Neoplasms
Liver Neoplasms
Keywords: Multimodal
Tislelizumab
lenvatinib
TACE
unresectable primary liver cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR) according to RECIST 1.1 and mRECIST
timeFrame: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
Secondary outcomes:
measure: Progression-Free Survival（PFS）
timeFrame: Follow-up for 12 months,with assessments conducted every 3 months.
measure: Overall Survival（OS）
timeFrame: Follow-up for 12 months,with assessments conducted every 3 months.
measure: Safety and Tolerability
timeFrame: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
Other outcomes:
Locations:
Study officials:
References: