RecruitingNCT05717738

Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Combined Transarterial Chemoembolization, Tyrosine Kinase Inhibitor/ Anti-VEGF Antibody, and Anti-PD-1/ PD-L1 Antibody as Conversion Therapy for Advanced Hepatocellular Carcinoma: a Multicenters, Real-world, Ambispective Cohort Study

Sponsor

Tongji Hospital

Enrollment

300 participants

Start Date

Jan 20, 2022

Study Type

OBSERVATIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

Summary

The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of transarterial chemoembolization (TACE), Anti-VEGF antibodies or pan-target anti-angiogenic drugs, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment strategy for patients with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed. The approach uses a mix of liver-directed therapy (TACE — chemotherapy delivered directly into the tumor's blood supply), targeted drugs (TKI/anti-VEGF), and immunotherapy (immune checkpoint inhibitors) with the goal of shrinking the tumor enough to make surgery possible. **You may be eligible if...** - You are 18 or older with confirmed advanced liver cancer that cannot currently be removed surgically, transplanted, or ablated - Your liver function is preserved (Child-Pugh class A or B7) - Your general health is good (ECOG score 0-1) - You have not previously received TACE or radioembolization **You may NOT be eligible if...** - You have advanced liver cirrhosis with major complications (fluid buildup, bleeding, or confusion) - You have had previous TACE or liver radioembolization - You have serious heart, lung, kidney, or autoimmune disease - You are pregnant or breastfeeding 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

PROCEDURETACE

Procedure of TACE is standardized.

DRUGLenvatinib

8mg; p.o.; q.d.

DRUGAnti-PD-1 monoclonal antibody

Advanced HCC Patients treated with TKI plus anti-PD-1 monoclonal antibody as systemic therapy were recruited. Anti-PD-1 monoclonal antibodies include pembrolizumab (200 mg, q3w), nivolumab (3mg/kg, q2w), camrelizumab (200mg, q2w), tislelizumab (200mg, q3w), sintilimab (200 mg, q3w), or toripalimab (240mg, q3w).

DRUGBevacizumab Biosimilar IBI305 plus sintilimab

Bevacizumab Biosimilar IBI305 (15mg/kg, q3w), and sintilimab (200 mg, q3w)

DRUGBevacizumab plus Atezolizumab

Bevacizumab (15mg/kg, q3w) plus Atezolizumab (1200 mg, q3w)

DRUGapatinib plus camrelizumab

Apatinib(250 mg; p.o.; q. d.); camrelizumab (200 mg; iv drip; q2w)

DRUGSorafenib

400mg; p.o. bid

DRUGDonafenib

200mg; p.o. bid

DRUGRegorafenib

160 mg; p.o.; q.d.