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

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04619329
Collaborator
(none)
78
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: GSMs-TACE
  • Procedure: Surgical Resection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Oct 30, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: GSMs-TACE+ Surgical Resection Group

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

    • Procedure: Surgical Resection
    Surgical Resection of HCC
    Other Names:
  • Hepatectomy

    		•
    Active Comparator: Surgical Resection Group

    Patients will receive surgical resection, as specified per protocol.

    Procedure: Surgical Resection
    Surgical Resection of HCC
    Other Names:
  • Hepatectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease Free Survival（DFS） [6 months]

    2. Median Overall Survival (mOS) [2 years]

    Secondary Outcome Measures

    1. Incidence of Intrahepatic Metastasis [6 months]

    2. Incidence of Extrahepatic Metastasis [1 and 2 years]

    3. Overall Survival (OS) [1 and 2 years]

    4. Adverse Events [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tsinghua Changgung Hospital Beijing China

    Sponsors and Collaborators

    • Beijing Tsinghua Chang Gung Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Tsinghua Chang Gung Hospital
    ClinicalTrials.gov Identifier:
    NCT04619329
    Other Study ID Numbers:
    • 20200-0-02
    First Posted:
    Nov 6, 2020
    Last Update Posted:
    Nov 30, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Nov 30, 2020