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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiiated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Zhenwei Peg, Dr.
pzhenw@mail.sysu.edu.cn
86+18620565282
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 500
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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