Actively Recruiting
Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma
Led by Nanjing Tianyinshan Hospital · Updated on 2025-07-02
300
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Individualized Comprehensive Treatment for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with hepatocellular carcinoma by cytology, tissue puncture, or clinical criteria, not eligible for radical treatments like surgery, ablation, or radiotherapy
- Disease progression after first-line targeted combined immune therapy according to RECIST1.1 criteria
- Life expectancy greater than 3 months
- ECOG physical condition score of 0 to 1
- Negative serum pregnancy test within 7 days before first medication for women of childbearing age
- Agreement to use contraception during the study for women of reproductive age and male partners of such women
- Laboratory test values before first dose: white blood cell count ≥ 2.0 × 10⁹/L, platelet count ≥ 60 × 10⁹/L, hemoglobin ≥ 8.0 g/dL
- Liver function: AST ≤ 2.5 times upper limit of normal (ULN), ALT ≤ 2.5 times ULN, total bilirubin ≤ 1.5 times ULN (≤ 3.0 mg/dL for Gilbert syndrome)
- Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min
- Coagulation: INR ≤ 1.5 times ULN, APTT ≤ 1.5 times ULN (patients on stable anticoagulant therapy allowed)
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Presence of other non-hepatocellular carcinoma types such as fibrolamellar, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma confirmed by histology or cytology
- Liver function classified as Child-Pugh grade 7 or higher
- Major cardiovascular issues within 6 months before treatment including heart failure (NYHA Class II or above), unstable angina, recent heart attack, stroke, or unstable arrhythmia; QTc interval > 480 ms
- Other cancers diagnosed within 5 years before treatment except fully treated cervical carcinoma in situ, skin cancers, local prostate cancer after surgery, and ductal carcinoma in situ after surgery
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Uncontrolled infections such as active tuberculosis or HIV; patients with controlled HBV-DNA under antiviral therapy may participate
- Major surgery within 28 days before randomization or planned major surgery during the study
- Use of live attenuated vaccines within 28 days before randomization or planned during the study; influenza vaccine restrictions apply
- Participation in another investigational drug study within 4 weeks prior to consent
- Use of corticosteroids over 10 mg/day prednisone equivalent or immunosuppressants within 14 days before first dose, with some exceptions
- Known mental illness, alcoholism, inability to quit smoking, or substance abuse
- Other factors judged by investigators that may cause early study termination such as non-compliance, serious illness, or social issues affecting safety or data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China Pharmaceutical University Affiliated Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
C
Chen Xun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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