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

Primary Purpose

Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GSMs-TACE
Surgical Resection
Sponsored by
Beijing Tsinghua Chang Gung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huge Hepatocellular Carcinoma (HCC) (≥10cm)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Beijing Tsinghua Changgung HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSMs-TACE+ Surgical Resection Group

Surgical Resection Group

Arm Description

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.

Patients will receive surgical resection, as specified per protocol.

Outcomes

Primary Outcome Measures

Disease Free Survival（DFS）
Median Overall Survival (mOS)

Secondary Outcome Measures

Incidence of Intrahepatic Metastasis
Incidence of Extrahepatic Metastasis
Overall Survival (OS)
Adverse Events

Full Information

First Posted
November 3, 2020
Last Updated
November 26, 2020
Sponsor
Beijing Tsinghua Chang Gung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04619329
Brief Title
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huge Hepatocellular Carcinoma (HCC) (≥10cm)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GSMs-TACE+ Surgical Resection Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgical Resection Group
Arm Type
Active Comparator
Arm Description
Patients will receive surgical resection, as specified per protocol.
Intervention Type
Device
Intervention Name(s)
GSMs-TACE
Other Intervention Name(s)
TACE
Intervention Description
TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)
Intervention Type
Procedure
Intervention Name(s)
Surgical Resection
Other Intervention Name(s)
Hepatectomy
Intervention Description
Surgical Resection of HCC
Primary Outcome Measure Information:
Title
Disease Free Survival（DFS）
Time Frame
6 months
Title
Median Overall Survival (mOS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of Intrahepatic Metastasis
Time Frame
6 months
Title
Incidence of Extrahepatic Metastasis
Time Frame
1 and 2 years
Title
Overall Survival (OS)
Time Frame
1 and 2 years
Title
Adverse Events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuewei Zhang
Phone
00861800115669
Email
zhangyuewei1121@sina.com.cn
Facility Information:
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuewei Zhang
Phone
00861800115669
Ext
+8618001156699
Email
zhangyuewei1121@sina.com.cn

12. IPD Sharing Statement

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

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