A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma

Sponsor
Fudan University
Study ID
NCT07328009
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hepato Cellular Carcinoma (HCC)

Eligibility Criteria

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

Interventions

  • Lenvatinib — DRUG
    12 mg orally daily for body weight ≥ 60 kg; 8 mg orally daily for body weight \< 60 kg.
  • Regorafenib (BAY 73-4506) — DRUG
    160 mg orally once daily on Days 1-21 of a 28-day cycle.
  • Tislelizumab+TKI — DRUG
    Tislelizumab:200 mg administered intravenously (IV) on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.
  • HAIC+TKI — DRUG
    FOLFOX Regimen: Administered via the hepatic artery. Oxaliplatin: 85 mg/m² IV infusion from Hour 0-2 on Day 1. Leucovorin: 400 mg/m² IV infusion from Hour 2-3 on Day 1. Fluorouracil: 400 mg/m² IV bolus at Hour 3 on Day 1, followed by 2400 mg/m² as a continuous IV infusion over 24 hours. HAIC was repeated every 3 weeks for up to 4 cycles. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.
  • HAIC + Tislelizumab+TKI — DRUG
    FOLFOX Regimen: Administered via the hepatic artery. Oxaliplatin: 85 mg/m² IV infusion from Hour 0-2 on Day 1. Leucovorin: 400 mg/m² IV infusion from Hour 2-3 on Day 1. Fluorouracil: 400 mg/m² IV bolus at Hour 3 on Day 1, followed by 2400 mg/m² as a continuous IV infusion over 24 hours.HAIC was repeated every 3 weeks for up to 4 cycles. Tislelizumab: 200 mg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.
  • QL1706+TKI — DRUG
    QL1706:7.5 mg/kg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.
  • HAIC + QL1706+TKI — DRUG
    FOLFOX Regimen: Administered via the hepatic artery. Oxaliplatin: 85 mg/m² IV infusion from Hour 0-2 on Day 1. Leucovorin: 400 mg/m² IV infusion from Hour 2-3 on Day 1. Fluorouracil: 400 mg/m² IV bolus at Hour 3 on Day 1, followed by 2400 mg/m² as a continuous IV infusion over 24 hours. HAIC was repeated every 3 weeks for up to 4 cycles. QL1706: 7.5 mg/kg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.
  • TUDCA + Camrelizumab+TKI — DRUG
    Tauroursodeoxycholic Acid (TUDCA): 250 mg orally twice daily. Camrelizumab: 200 mg IV on Day 1 of each 14-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.
  • XELOX + QL1706+TKI — DRUG
    Oxaliplatin, 85 mg/m² IV infusion on Day 1 every 3 weeks; Capecitabine, 1000 mg/m2, orally twice daily on days 1 to 14 every 3 weeks. XELOX was repeated every 3 weeks for up to 4 cycles. QL1706: 7.5 mg/kg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.
  • XELOX + Tislelizumab+TKI — DRUG
    Oxaliplatin, 85 mg/m² IV infusion on Day 1 every 3 weeks; Capecitabine, 1000 mg/m2, orally twice daily on days 1 to 14 every 3 weeks. XELOX was repeated every 3 weeks for up to 4 cycles. Tislelizumab: 200 mg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

Study Details

This is a phase II, multi-arm, Bayesian adaptive platform trial designed to efficiently evaluate novel therapies for advanced hepatocellular carcinoma (HCC) after first-line treatment failure. The study aims to rapidly identify the most effective investigational regimens and discover predictive biomarker signatures (from tumor tissue, blood, and imaging) to guide personalized second-line therapy.

Key Dates

Start date
Jan 19, 2026
Status verified
Dec 2025
Primary completion
Jan 15, 2029
Completion
Jan 15, 2029

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TKI (Control Therapy)
    Lenvatinib OR Regorafenib
  • Experimental: Tislelizumab+TKI
    Tislelizumab+TKI
  • Experimental: HAIC+TKI
    HAIC (Hepatic Arterial Infusion Chemotherapy)+TKI
  • Experimental: HAIC + Tislelizumab+TKI
    HAIC + Tislelizumab+TKI
  • Experimental: QL1706+TKI
    QL1706 (iparomlimab/tuvonralimab)+TKI
  • Experimental: HAIC + QL1706+TKI
    HAIC + QL1706+TKI
  • Experimental: TUDCA + Camrelizumab+TKI
    TUDCA + Camrelizumab+TKI
  • Experimental: XELOX + Tislelizumab+TKI
    XELOX (chemotherapy) + Tislelizumab+TKI
  • Experimental: XELOX + QL1706+TKI
    XELOX (chemotherapy) + Tislelizumab+TKI

Primary Outcome Measure

Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: max 24 months ]

Central Contacts