Huge Hepatocellular Carcinoma (HCC) (≥10cm)
Conditions
Brief summary
A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).
Interventions
DEVICEGSMs-TACE
TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)
PROCEDURESurgical Resection
Surgical Resection of HCC
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed imaging and pathological diagnosis of HCC, or diagnosed for the first time according to the guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition). 2. Barcelona Clinic Liver Cancer (BCLC) stage A or B. 3. Remnant liver volume and liver function reserve are suitable for surgical resection. 4. Main lesion diameter ≥10cm. 5. Number of HCC lesions ≤5 and all located on one liver lobe. 6. Liver function Child-Pugh class A 7. ECOG Performance Status 0-1 8. Life expectancy ≥ 6 months 9. HCC is diagnosed for the first time. 10. Age 18 to 75 years 11. Able to sign and provide written informed consent.
Exclusion criteria
1. Severe active infection \>grade 2 (except for Hepatitis B and C infection). 2. Liver function Child-Pugh class C. 3. BCLC stage C. 4. Patients with unresectable HCC. 5. Platelet \<60×109/L. 6. Concomitant malignant tumors in other organs. 7. Patient with severe cardiac, lung or kidney disease, or severe diabetes. 8. Pregnant or breast-feeding woman. 9. Patients with severe neuropathy and unable to report therapeutic effects. 10. Patients with severe atherosclerosis. 11. Patients with AIDS. 12. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment. 13. Severe thrombogenesis or embolic event within the 6 months prior to enrolment. 14. Currently enrolled or going to enroll in any other clinical trials. 15. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance，inability to follow up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival（DFS） | 6 months |
| Median Overall Survival (mOS) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Intrahepatic Metastasis | 6 months |
| Incidence of Extrahepatic Metastasis | 1 and 2 years |
| Overall Survival (OS) | 1 and 2 years |
| Adverse Events | 6 months |
Countries
China
Contacts
Primary ContactYuewei Zhang
Outcome results
None listed