Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma
NCT06893887 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-07-02
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
- 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 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.
Sponsors & Collaborators
-
Nanjing Tianyinshan Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-22
- Primary Completion
- 2027-03-15
- Completion
- 2028-03-15
Countries
- China
Study Locations
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