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Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04619342
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
3.8
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 the Treatment of Hepatocellular Carcinoma (HCC) with Type III Portal Vein Tumor Thrombus (PVTT).

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 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 the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT): A Single Center, Open, Randomized Controlled Trial.
Actual Study Start Date :
Oct 30, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

After TACE using epirubicin and GSMs (150-350μm or 350-560μm), patients that meet certain criteria will receive surgical resection of PVTT, as specified per protocol.

Device: GSMs-TACE
TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)
Other Names:
  • TACE

    • Procedure: Surgical Resection
    Surgical Resection of PVTT
    Active Comparator: GSMs-TACE Group

    Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol.

    Device: GSMs-TACE
    TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)
    Other Names:
  • TACE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival（PFS） [6 months]

      PFS is defined as the time from Day 1 of treatment until the progression of a target lesion or the appearance of new lesions.

    Secondary Outcome Measures

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

    2. Overall Survival [3, 6, 12 and 18 months]

    3. 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 diagnosis of HCC with PVTT involving the main portal vein, i.e. Type III PVTT according to Cheng's classification.

    2. Confirmed abundant blood supply of tumor thrombus using Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).

    3. The tumor must be surgically resectable.

    4. ECOG Performance Status 0-2.

    5. Adequate liver function (Child-Pugh class A)

    6. Life expectancy ≥ 3 months

    7. Previous physical ablation is allowed.

    8. Age 18 to 75 years

    9. Able to sign and provide written informed consent.

    Exclusion Criteria:

    1. Patients previously took oral molecular targeted drug or received immunotherapy.

    2. Patients with arteriovenous fistula.

    3. Severe active infection >grade 2 (except for Hepatitis B and C infection).

    4. Concomitant malignant tumors in other organs.

    5. Presence of severe cardiac, lung or kidney disease.

    6. Pregnant or breast-feeding woman.

    7. Patients with severe neuropathy and unable to report therapeutic effects.

    8. Patients with severe atherosclerosis.

    9. Patients with AIDS.

    10. Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.

    11. Severe thrombogenesis or embolic event within the 6 months prior to enrolment.

    12. Currently enrolled or going to enroll in any other clinical trials.

    13. 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 Changgung Hospital Beijing China

    Sponsors and Collaborators

    • Beijing Tsinghua Chang Gung Hospital

    Investigators

    • Principal Investigator: Yuewei Zhang, Beijing Tsinghua Changgeng Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Tsinghua Chang Gung Hospital
    ClinicalTrials.gov Identifier:
    NCT04619342
    Other Study ID Numbers:
    • 20304-0-01
    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
    Thrombosis

    Study Results

    No Results Posted as of Nov 30, 2020