RecruitingNCT05713994

Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

Combined Hepatic Arterial Infusion Chemotherapy, Tyrosine Kinase Inhibitor/ Anti-VEGF Antibody, and Anti-PD-1/ PD-L1 Antibody as Conversion Therapy for Unresectable Hepatocellular Carcinoma

Sponsor

Ze-yang Ding, MD

Enrollment

300 participants

Start Date

May 19, 2020

Study Type

OBSERVATIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

Summary

This study is conducted to evaluate the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of hepatic artery infusion chemotherapy (HAIC), tyrosine kinase inhibitor/ anti-VEGF antibody, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation. Factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach — hepatic arterial infusion chemotherapy (HAIC, delivered directly into the liver artery), targeted therapy drugs, and immunotherapy — to shrink liver cancer (hepatocellular carcinoma) enough to make it operable when it was initially considered inoperable. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of liver cancer (hepatocellular carcinoma) - Your tumor has been assessed as not suitable for surgery, transplant, or ablation by a multidisciplinary team - You have reasonable liver function (Child-Pugh A or B7) - Your overall health status is good (ECOG 0 or 1) - You may be eligible even with limited portal vein involvement or limited spread to nearby vessels or outside the liver (up to 3 lesions in 2 organs) **You may NOT be eligible if...** - You have had prior liver treatment including TACE or radioembolization - Your liver tumor extends into major blood vessels near the heart - You have widespread disease outside the liver (more than 3 metastatic lesions or in more than 2 organs) - You have severely impaired liver function (Child-Pugh C) - You have serious kidney or heart conditions preventing treatment 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

PROCEDUREHAIC

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.

DRUGBevacizumab plus Atezolizumab

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

DRUGBevacizumab Biosimilar IBI305 plus sintilimab

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

DRUGLenvatinib

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

DRUGSorafenib

400mg; p.o. bid

DRUGDonafenib

200mg; p.o. bid

DRUGRegorafenib

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

DRUGapatinib plus camrelizumab

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

DRUGAnti-PD-1 monoclonal antibody

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).