RecruitingPhase 2NCT06405061

Evaluation of Effectiveness and Safety of HAIC in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma

A Prospective, Single-arm, Multicenter Phase II Clinical Study of Hepatic Arterial Perfusion Chemotherapy (FOLFOX) in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

40 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Primary liver cancer mainly consists of three different pathologic types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hybrid HCC-ICC, of which HCC accounts for 90%. According to GLOBOCAN 2018 data, liver cancer is the sixth most prevalent tumor in the world, with about 841,100 new liver cancer cases and 781,600 deaths per year globally, which is the second leading cause of tumor deaths in men worldwide. China is a high incidence area of liver cancer, accounting for about 50% of the global incidence and deaths. The treatment of HCC varies according to disease stage, which is based on the BCLC classification system, Child-Pugh liver function rating, and extent of disease. Approximately 30% of HCC cases are diagnosed in the early stages (i.e., BCLC stage 0 or A), and the main treatment options include surgical resection, ablation techniques, and liver transplantation. However, the 5-year recurrence rate remains as high as 70%. The recommended treatment for intermediate stage HCC (i.e., BCLC stage B) is hepatic artery intervention, i.e., transarterial chemoembolization (TACE), but the scope of applicability is limited due to concomitant disease and liver impairment factors, some patients do not derive a survival benefit from it, and patients ultimately progress after treatment and are no longer suitable for further TACE. In recent years, the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted, and studies have reported the feasibility of target drugs combined with ICI, TACE or HAIC for the treatment of unresectable hepatocellular carcinoma. The therapeutic aim of Adebrelimab (SHR-1316) is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells, so that T cells can re-recognize tumor cells and produce killing effects on them. This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy (FOLFIRI) in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination treatment — hepatic artery infusion chemotherapy (HAIC, a targeted delivery of chemotherapy directly into liver blood vessels), plus an immunotherapy drug (adebrelimab), and targeted therapy (a TKI) — for patients with intermediate to advanced liver cancer (hepatocellular carcinoma, or HCC). **You may be eligible if...** - You are between 18 and 75 years old with a confirmed diagnosis of liver cancer (HCC) - Your cancer is at an intermediate to advanced stage (stage IIb–IIIa with limited portal vein involvement) - You have not received any prior treatment for liver cancer - Your liver function is adequate (Child-Pugh score of 7 or less) - Your general health score is 0 or 1 and expected survival is at least 12 weeks - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have already received treatment for liver cancer - Your liver function is too poor (Child-Pugh score above 7) - Your cancer has spread extensively to portal veins or beyond the criteria above - You have active bleeding, severe blood clotting problems, or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

Adebrelimab: 1200 mg, IV, q3w


Locations(4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Third Central Hospital of Tianjin

Tianjin, Tianjin Municipality, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06405061


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