Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma

Sponsor
Nanjing Tianyinshan Hospital
Study ID
NCT06893887
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma(HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX4 — DRUG
    FOLFOX4 was administered by oxaliplatin 85 mg/m² d1+ leucovorin 200 mg/m² d1-2+ fluorouracil 400 mg/m² 2 h→ 600 mg/m² 24 h d1-2 q2w, with a total of 4 cycles
  • Adebrelimab — DRUG
    Adebrelimab 1200mg, intravenous infusion, every 3 weeks
  • Apatinib — DRUG
    Apatinib 250mg, oral, once daily.
  • Icaritin — DRUG
    Epimedium extract soft capsules 2.4g, oral, 2 times daily.
  • SHR-1701 — DRUG
    SHR1701，30mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.
  • QL1706 — DRUG
    QL1706，5mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.
  • Bevacizumab — DRUG
    Bevacizumab 7.5mg, intravenous infusion, once every 3 weeks.
  • HAIC — PROCEDURE
    Hepatic Arterial Infusion Chemotherapy
  • Local treatment — PROCEDURE
    Local treatment of oligo-metastases.
  • The original treatment regimen — DRUG
    Continue the original targeted therapy combined with immunotherapy. dosage, dosage form,frequency of administration was the same as before.

Study Details

This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Based on different patterns of disease progression, patients will receive relevant systemic treatments, either with or without local interventional therapy. The primary endpoint is progression-free survival (PFS), while secondary endpoints include overall survival (OS), 1-year OS rate, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and safety. Additionally, the study will explore the correlation between patients' clinical pathological characteristics, serum biomarkers, and clinical efficacy.

Key Dates

Start date
May 22, 2025
Status verified
Jun 2025
Primary completion
Mar 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    XELOX/FOLFOX4+ Adebelizumab + Apatinib+Icaritin
  • Experimental: Arm 2
    Adebelizumab + Apatinib+Icaritin
  • Experimental: Arm 3
    SHR1701+ Apatinib+Icaritin
  • Experimental: Arm 4
    QL1706+ Apatinib+Icaritin
  • Experimental: Arm 5
    The original targeted combination immunotherapy+HAIC
  • Experimental: Arm 6
    SHR1701+ Apatinib+Icaritin，intrahepatic progression
  • Experimental: Arm 7
    QL1706+ Apatinib+Icaritin，extrahepatic progression
  • Experimental: Arm 8
    SHR1701+Bevacizumab+Icaritin
  • Experimental: Arm 9
    QL1706+Bevacizumab+Icaritin
  • Experimental: Arm 10
    Local treatment of oligometastases (such as radiotherapy, RFA, etc.) + the original targeted and immunotherapy.

Primary Outcome Measure

PFS（Progression-free Survival） [ Time Frame: 24 months ]

Central Contacts