FAD Subtype-Guided Combination Therapy for Unresectable Hepatocellular Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

This study is a prospective, multicenter Phase II trial evaluating a personalized treatment strategy for patients with unresectable hepatocellular carcinoma (HCC). The study uses a metabolic classification system called the fatty acid degradation (FAD) subtype to guide therapy selection. Patients will be assigned to different treatment groups based on their tumor's FAD subtype, determined through RNA-seq analysis of the tumor tissue obtained from liver biopsy.

Eligibility criteria

Qualifiers

Adults ≥18 years of age who voluntarily agree to participate and sign informed consent.

Histologically or cytologically confirmed hepatocellular carcinoma (HCC).

Unresectable or not suitable for curative local therapy, or progression after prior surgery or local therapy.

BCLC stage B or C.

Disqualifiers

Non-HCC primary liver cancers (e.g., cholangiocarcinoma, combined HCC-CCA).

F3 subtype without liver lesions on imaging.

Clinically significant ascites requiring therapeutic intervention, or uncontrolled pleural/pericardial effusion.

Interstitial lung disease, pneumonitis requiring steroids, or active pulmonary infection.

Trial design

Treatments tested in this trial

  • Camrelizumab Plus Apatinib
  • TACE Plus Camrelizumab and Apatinib

Treatment groups

86 Participants
are divided into 2 treatment groups