Prospective Collection of Therapeutic Efficacy and Safety Data in Patients with Unresectable Hepatocellular Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe a combination of treatments is for patients with unresectable hepatocellular carcinoma (a type of liver cancer that cannot be surgically removed). Specifically, it aims to explore the use of transarterial chemoembolization (TACE), a standard treatment, alongside targeted therapies or immunotherapy. While TACE can extend survival for some patients, researchers want to find out if combining it with other therapies can improve outcomes even more. The trial will collect data from patients treated at the hospital between March 2023 and March 2025.

To participate, patients must be between 18 and 75 years old and diagnosed with primary unresectable liver cancer that has not been previously treated. They should have measurable liver tumors and generally good health, with liver function classified as Child-Pugh grade A. Participants can expect to undergo the TACE treatment and may receive additional therapies while being closely monitored for safety and effectiveness. This trial is crucial as it seeks to discover better treatment options for patients facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1, age 18-75 years old; 2. Patients with primary unresectable liver cancer who have not received any previous treatment (in accordance with the AASLD 2018/EASL 2018 Liver Cancer Diagnostic guidelines); Or patients with unresectable liver cancer who recurred for the first time after radical therapy and did not receive any postoperative adjuvant therapy; 3. There is at least one lesion in the liver that can be measured according to mRECIST criteria, and the intrahepatic lesion is a single tumor ≤10.0cm or multiple tumors (the number of tumors ≤10) and the tumor load is less than 50% (three-dimensional reconstruction of CT scan using Vitelacore software \[version: 6.9.87.1, Canon\], calculated as proportion of tumor volume to total liver volume) 4. Normal liver tissue volume exceeds 700ml 5, ECOG score 0-1, good general condition 6, liver function Child-Pugh grade A 7. Expected survival time ≥3 months 8. Blood, liver and kidney function meet the following conditions: a) Neutrophil count ≥1.5×109/L b) Platelet count ≥60×109/L c) Hemoglobin concentration ≥90g/L d) Serum albumin concentration ≥30g/L e) bilirubin ≤50umol/L f) AST and ALT were 5 times lower than the upper limit of normal, ALP less than 4 times the upper limit of normal g) prothrombin time less than 6 seconds above the upper limit of normal h) creatinine less than 1.5 times the upper limit of normal
• Exclusion Criteria:
• • 1. Preoperative imaging examination assessed tumor load \>50%;
• • 2. Previous history of hepatic encephalopathy, refractory ascites, or esophageal and gastric varices rupture bleeding;
• • 3. There are contraindications for TACE treatment, such as portal shunt, isolated hepatic blood flow, and obvious atherosclerosis;
• • 4. Patients with extrahepatic metastasis;
• • 5. Allergic to intravenous contrast agents;
• • 6. Pregnant or lactating women or subjects who plan to have a family within two years; 7, accompanied by HIV, syphilis infection;
• • 8. Accompanied by other malignant tumors or had other malignant tumors within 5 years prior to enrollment; 9. Allogeneic organ transplants; 10, serious heart, kidney and other organ dysfunction; 11. Active clinical severe infection \> Grade 2; 12. Suffering from mental illness may affect informed consent; 13, can not take oral medicine; 14. Participated in other drug clinical trials within 12 months before enrollment; 15. Active gastric or duodenal ulcer occurred 3 months before enrollment; 16. Previous history of liver or adjacent tissue radiotherapy