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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with unresectable primary liver cancer, specifically hepatocellular carcinoma (HCC). The study combines several therapies, including a procedure called TACE (transarterial chemoembolization), a type of immunotherapy using Tislelizumab, and a targeted therapy called Lenvatinib. The goal is to see how effective and safe this combination treatment is for people whose tumors cannot be surgically removed.

To qualify for this trial, participants need to be between 18 and 80 years old and have a confirmed diagnosis of HCC at certain stages (IIb-IIIa) where the tumors cannot be surgically removed. They should also have a specific type of liver function and have not received previous treatments like chemotherapy or immunotherapy for their cancer. If eligible, participants will be monitored closely during the trial to assess how well the treatment works and to watch for any side effects. It's important to note that this trial is not yet recruiting participants, so it will be starting in the future.

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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.