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

Huge Hepatocellular Carcinoma (HCC) (=10cm) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619329
• Other study ID #: 20200-0-02
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Yuewei Zhang
• Phone: 00861800115669
• Email: zhangyuewei1121[@]sina.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Huge Hepatocellular Carcinoma (HCC) (=10cm)

Intervention

Device:
• GSMs-TACE
TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350µm, 350-560µm, 560-710µm or 710-1000µm)

Procedure:
• Surgical Resection
Surgical Resection of HCC

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival(DFS)		6 months
Primary	Median Overall Survival (mOS)		2 years
Secondary	Incidence of Intrahepatic Metastasis		6 months
Secondary	Incidence of Extrahepatic Metastasis		1 and 2 years
Secondary	Overall Survival (OS)		1 and 2 years
Secondary	Adverse Events		6 months