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

Not Applicable

• Conditions: Huge Hepatocellular Carcinoma (HCC) (≥10cm)
• Interventions: Device: GSMs-TACE; Procedure: Surgical Resection

• Registration Number: NCT04619329
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-30
• Status Verified: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-06
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSMs-TACE+ Surgical Resection Group	GSMs-TACE	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.
GSMs-TACE+ Surgical Resection Group	Surgical Resection	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.
Surgical Resection Group	Surgical Resection	Patients will receive surgical resection, as specified per protocol.

Primary Outcome Measures

Name	Time	Method
Disease Free Survival（DFS）	6 months
Median Overall Survival (mOS)	2 years

Secondary Outcome Measures

Name	Time	Method
Adverse Events	6 months
Incidence of Extrahepatic Metastasis	1 and 2 years
Incidence of Intrahepatic Metastasis	6 months
Overall Survival (OS)	1 and 2 years

Trial Locations

Locations (1)

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, China