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RECRUITING
NCT06893887
NA

Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma

Sponsor: Nanjing Tianyinshan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-05-22

Completion Date

2028-03-15

Last Updated

2025-07-02

Healthy Volunteers

No

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

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.

Locations (1)

China Pharmaceutical University Affiliated Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China