NCT06893887

Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma

Exploratory Cohort Study and Mechanistic Research on Individualized Comprehensive Treatment After Standard Treatment for Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Nanjing Tianyinshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatocellular Carcinoma(HCC)

Interventions

Type	Name	Description
DRUG	FOLFOX4	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
DRUG	Adebrelimab	Adebrelimab 1200mg, intravenous infusion, every 3 weeks
DRUG	Apatinib	Apatinib 250mg, oral, once daily.
DRUG	Icaritin	Epimedium extract soft capsules 2.4g, oral, 2 times daily.
DRUG	SHR-1701	SHR1701，30mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.
DRUG	QL1706	QL1706，5mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.
DRUG	Bevacizumab	Bevacizumab 7.5mg, intravenous infusion, once every 3 weeks.
PROCEDURE	HAIC	Hepatic Arterial Infusion Chemotherapy
PROCEDURE	Local treatment	Local treatment of oligo-metastases.
DRUG	The original treatment regimen	Continue the original targeted therapy combined with immunotherapy. dosage, dosage form,frequency of administration was the same as before.

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-03-15
• Completion: 2028-03-15
• First posted: 2025-03-25
• Last updated: 2025-07-02

Locations

1 site across 1 country: China