Actively Recruiting

Age: 18Years +
All Genders
NCT05713994

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

Led by Ze-yang Ding, MD · Updated on 2025-03-25

300

Participants Needed

2

Research Sites

293 weeks

Total Duration

On this page

Sponsors

Z

Ze-yang Ding, MD

Lead Sponsor

C

Chinese Cooperative Group of Liver Cancer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with hepatocellular carcinoma according to established guidelines
  • At least one measurable tumor lesion based on RECIST v1.1 or mRECIST
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • HCC deemed unsuitable for surgery, transplant, or ablation by a multidisciplinary team due to specific criteria such as insufficient liver remnant volume or advanced disease stage
  • Portal vein involvement allowed within defined classifications (Chen's groups A and B, Cheng's types I-III)
  • Hepatic vein invasion allowed up to certain types; exclusion if tumor thrombus extends above the diaphragm or into the right atrium
  • Extrahepatic oligometastasis allowed with up to three metastatic lesions in up to two organs, each ≤3 cm
  • Child-Pugh liver function class A or B7
  • No prior liver transplantation, transarterial chemoembolization (TACE), or radioembolization; prior local therapies allowed if disease progressed and completed ≥4 weeks before baseline
  • Adequate organ and marrow function as defined by specific laboratory values
Not Eligible

You will not qualify if you...

  • Prior invasive malignancy within 2 years except certain noninvasive cancers that have been surgically cured
  • Severe, active, uncontrolled medical conditions including infections (except HBV and HCV), heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina, arrhythmias, active interstitial lung disease, severe chronic gastrointestinal disease, psychiatric or social problems impairing consent
  • History of active primary immunodeficiency or HIV
  • Active or previous autoimmune or inflammatory diseases including inflammatory bowel disease, lupus, sarcoidosis, vasculitis, rheumatoid arthritis, and others
  • History of hepatic decompensation such as refractory ascites, gastrointestinal bleeding, or encephalopathy
  • Known allergy or hypersensitivity to any study drug or its components
  • Significant gastrointestinal bleeding or risk of bleeding within 30 days before study entry
  • Tumors in the central nervous system including brain metastases
  • Pregnant or breastfeeding women
  • Prior anti-tumor systemic therapy for HCC; hormone therapy for non-anti-tumor purposes excluded
  • Use of immunosuppressive drugs within 14 days prior to first dose except specified exceptions
  • Live attenuated vaccine within 30 days prior to first study drug dose
  • Extrahepatic vascular involvement or thrombosis exceeding specified limits such as superior mesenteric vein type IV or certain tumor thrombi in the inferior vena cava or right atrium

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China, 362000

Actively Recruiting

2

TongjiHospital

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

Z

ZeYang Ding, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

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