A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma
The HCC-SIGHT: A Therapy Platform Trial for Hepatocellular Carcinoma Guided by Stratification Imaging and Genetic Horizon Testing
Fudan University
350 participants
Jan 19, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
12 mg orally daily for body weight ≥ 60 kg; 8 mg orally daily for body weight \< 60 kg.
160 mg orally once daily on Days 1-21 of a 28-day cycle.
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.
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.
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.
QL1706:7.5 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.
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.
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.
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.
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.
Locations(1)
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NCT07328009