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

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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Hepatocellular Carcinoma; Transarterial Chemoembolization; Systemic Therapy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Zhenwei Peg, Dr.; Phone Number: 86+18620565282; Email: pzhenw@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiiated Hospital of Sun Yat-sen University
      • Contact: The First Affiliated Hospital of Sun Yat-sen University; Phone Number: 020-87755766; Email: zsyyyb@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study populations in this study are patients with primary unresectable liver cancer who have not received any previous treatment or patients with unresectable liver cancer who recurred for the first time after radical therapy and did not receive any postoperative adjuvant therapy;

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
TACE alone; TACE with either cTACE or DEB-TACE can be used, depending on the selection of the patient and the physician.
TACE plus systemic therapy; TACE with either cTACE or DEB-TACE can be used, depending on the selection of the patient and the physician. Systemic therapy includes target therapies and immunotherapies. Monotherapy and the combined therapy can be used, depending on the selection of the patient and the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Defined as the time from commencement of enrollment to progression of disease or death throughout the trial. Patients who withdraw or are lost to follow-ups will be treated as censored data, and the last date of known living without progression will be used as the last survival time. Patients whose diseases have not progressed at ending of this study will be treated as censored data, and the last date of known living without progression will be used as the last survival time.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Defined as the time from the commencement of enrollment to all-cause death throughout the trial. Patients who withdraw or are lost to follow-ups will be treated as censored data, and the last date of known living will be used as the last survival time. Patients who still survive at ending of this study will also be treated as censored data, and the last date of known living is used as the last survival time.	24 months
tumor response	tumor response is evaluated based on mRECIST and RECIST v1.1 criteria, including complete response, partial response, stable disease, and progression disease.	24 months
Safety	Defined as one of ≥ grade 3 hematologic or non-hematologic toxicity events. The severity of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0).	24 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: [2023]546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No