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)
NCT ID: NCT04619342
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
98 participants
INTERVENTIONAL
2020-10-30
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
GSMs-TACE
TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)
Surgical Resection
Surgical Resection of PVTT
GSMs-TACE Group
Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol.
GSMs-TACE
TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)
Interventions
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GSMs-TACE
TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)
Surgical Resection
Surgical Resection of PVTT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
75 Years
ALL
No
Sponsors
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Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuewei Zhang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tsinghua Changgeng Hospital
Locations
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Beijing Changgung Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Yuewei Zhang
Role: primary
Other Identifiers
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20304-0-01
Identifier Type: -
Identifier Source: org_study_id