RecruitingNot ApplicableNCT06893887

Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma

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


Sponsor

Nanjing Tianyinshan Hospital

Enrollment

300 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized combination treatment approach for people with advanced liver cancer (hepatocellular carcinoma) who have already tried and stopped responding to their first-line treatment (targeted therapy plus immunotherapy). The goal is to find better options for this difficult-to-treat stage. **You may be eligible if...** - You are 18 or older - You have been diagnosed with liver cancer (HCC) confirmed by biopsy or imaging - Your cancer cannot be treated with surgery or other local treatments - Your cancer has gotten worse despite first-line targeted immunotherapy treatment - Your expected survival is more than 3 months and your physical function is good (ECOG 0-1) **You may NOT be eligible if...** - You are pregnant or of childbearing age and not using contraception - You have not yet tried standard first-line treatments - You have serious organ problems or very poor overall health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFOLFOX4

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

DRUGAdebrelimab

Adebrelimab 1200mg, intravenous infusion, every 3 weeks

DRUGApatinib

Apatinib 250mg, oral, once daily.

DRUGIcaritin

Epimedium extract soft capsules 2.4g, oral, 2 times daily.

DRUGSHR-1701

SHR1701,30mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.

DRUGQL1706

QL1706,5mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most.

DRUGBevacizumab

Bevacizumab 7.5mg, intravenous infusion, once every 3 weeks.

PROCEDUREHAIC

Hepatic Arterial Infusion Chemotherapy

PROCEDURELocal treatment

Local treatment of oligo-metastases.

DRUGThe 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

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NCT06893887


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