Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Study Overview
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Brief Summary
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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).

Official Title
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Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm): A Single Center, Open, Randomized Controlled Trial.

Conditions
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Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Intervention / Treatment
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* Device: GSMs-TACE
* Procedure: Surgical Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Barcelona Clinic Liver Cancer (BCLC) stage A or B. Remnant liver volume and liver function reserve are suitable for surgical resection. Main lesion diameter ≥10cm. Number of HCC lesions ≤5 and all located on one liver lobe. Liver function Child-Pugh class A ECOG Performance Status 0-1 Life expectancy ≥ 6 months HCC is diagnosed for the first time. Age 18 to 75 years Able to sign and provide written informed consent. Exclusion Criteria: Severe active infection >grade 2 (except for Hepatitis B and C infection). Liver function Child-Pugh class C. BCLC stage C. Patients with unresectable HCC. Platelet <60×109/L. Concomitant malignant tumors in other organs. Patient with severe cardiac, lung or kidney disease, or severe diabetes. Pregnant or breast-feeding woman. Patients with severe neuropathy and unable to report therapeutic effects. Patients with severe atherosclerosis. Patients with AIDS. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment. Severe thrombogenesis or embolic event within the 6 months prior to enrolment. Currently enrolled or going to enroll in any other clinical trials. Subject is not suitable to participate in the study as judged by investigator (poor patient compliance，inability to follow up).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSMs-TACE+ Surgical Resection Group<br>After TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol. | Device: GSMs-TACE<br>* TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)<br>* Other names: TACE;Procedure: Surgical Resection<br>* Surgical Resection of HCC<br>* Other names: Hepatectomy;|
| Active Comparator: Surgical Resection Group<br>Patients will receive surgical resection, as specified per protocol. | Procedure: Surgical Resection<br>* Surgical Resection of HCC<br>* Other names: Hepatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival（DFS） |  | 6 months | 
| Median Overall Survival (mOS) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |