Collecting data on treatment effectiveness and safety for patients with advanced liver cancer

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

This study is testing how well a combination of a specific cancer treatment and immunotherapy works for patients with advanced liver cancer who haven't been treated before or have had their cancer come back.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06788353 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data on the efficacy and safety of transarterial chemoembolization (TACE) combined with targeted or immunotherapy in patients with unresectable hepatocellular carcinoma. It focuses on patients who have not received prior treatment or those who have experienced recurrence after radical therapy. The study will assess the impact of these treatment combinations on patient outcomes, including overall survival and progression-free survival. By analyzing the collected data, the study seeks to identify the most effective treatment strategies for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with primary unresectable liver cancer who have not undergone previous treatment or have had a recurrence after radical therapy.

Not a fit: Patients with liver cancer that is resectable or those who have received prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment combinations for patients with unresectable liver cancer, potentially improving their survival rates.

How similar studies have performed: While some studies have explored combinations of TACE and systemic therapies, the efficacy of these approaches remains uncertain, making this study's focus on observational data collection particularly relevant.

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

Where this trial is running

Guangzhou, Guangdong

• The First Affiiated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhenwei Peg, Dr.

Conditions Transarterial Chemoembolization; Systemic Therapy; Unresectable Hepatocellular Carcinoma