Actively Recruiting
Prospective Collection of Therapeutic Efficacy and Safety Data in Patients with Unresectable Hepatocellular Carcinoma
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 malignant degree of middle and advanced liver cancer is very high, and the survival prognosis of patients is very poor. TACE is currently the standard treatment for unresectable liver cancer recommended by several international authoritative guidelines. However, TACE can only extend survival from 8 months to 13 months, and the prognosis for patients with unresectable liver cancer is still not optimistic. In recent years, some studies have suggested that the combination of TACE and systemic therapy can prolong OS and PFS, but a number of prospective studies have found that the combination of TACE and targeted therapy can not improve the prognosis of unresectable liver cancer. However, TACE as a non-radical treatment is difficult to achieve complete tumor necrosis, so it is still unknown which treatment combination can best improve the prognosis. This trial is an observational clinical trial to explore the efficacy and safety of TACE combined targeting/immunotherapy for unresectable hepatocellular carcinoma. Clinical data of patients with unresectable liver cancer treated in our hospital from March 2023 to March 2025 are intended to be collected to evaluate the efficacy and safety of TACE combined with different systems for unresectable liver cancer.
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
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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
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