Actively Recruiting
Prospective Collection of Therapeutic Efficacy and Safety Data in Patients with Unresectable Hepatocellular Carcinoma Observational Study of TACE Combined with Systemic Therapy
Led by Sun Yat-sen University · Updated on 2025-01-23
500
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial focuses on patients with unresectable hepatocellular carcinoma, a severe form of liver cancer with poor survival outcomes. It aims to explore the effectiveness and safety of combining transarterial chemoembolization (TACE), a common treatment for this cancer, with targeted or immunotherapy. The study observes patients treated at the hospital between March 2023 and March 2025 to understand which treatment combinations might improve prognosis beyond current standards. Participants receive TACE combined with different systemic therapies to evaluate potential benefits. The study collects clinical data without specifying particular experimental drugs or devices, as it is observational. The goal is to assess how these combined treatments impact the course of unresectable liver cancer and to identify the best approach for improving patient outcomes. During the study, patients will be monitored for progression-free survival over 24 months. Researchers will evaluate tumor response based on imaging and clinical assessments while tracking safety and side effects. Participants must meet specific health and liver function criteria to join, and their progress will be followed with regular clinical evaluations throughout the study period.
CONDITIONS
Official Title
Prospective Collection of Therapeutic Efficacy and Safety Data in Patients with Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Diagnosed with primary unresectable liver cancer without prior treatment, or first recurrence after radical therapy without postoperative adjuvant treatment
- At least one measurable liver lesion by mRECIST criteria; single tumor ≤10.0 cm or up to 10 tumors with total tumor load less than 50% of liver volume
- Normal liver tissue volume over 700 ml
- ECOG performance status score of 0-1 indicating good general condition
- Liver function classified as Child-Pugh grade A
- Expected survival time of 3 months or more
- Adequate blood, liver, and kidney function based on specified laboratory values
You will not qualify if you...
- Tumor load greater than 50% by preoperative imaging
- History of hepatic encephalopathy, refractory ascites, or bleeding from esophageal or gastric varices
- Contraindications to TACE such as portal shunt, isolated hepatic blood flow, or severe atherosclerosis
- Presence of extrahepatic metastasis
- Allergy to intravenous contrast agents
- Pregnant or breastfeeding, or planning pregnancy within 2 years
- Infection with HIV or syphilis
- Other malignant tumors currently or within last 5 years
- History of allogeneic organ transplant
- Serious dysfunction of heart, kidney, or other organs
- Active severe infection above Grade 2
- Mental illness that could affect consent
- Unable to take oral medication
- Participation in other drug trials within past 12 months
- Active gastric or duodenal ulcer within 3 months
- Prior liver or adjacent tissue radiotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiiated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Z
Zhenwei Peg, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Frequently Asked Questions
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