Back to resultsSafety and Efficacy of GSMs-TACE Combined With Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)
Primary Purpose
Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GSMs-TACE
Surgical Resection
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of HCC with PVTT involving the main portal vein, i.e. Type III PVTT according to Cheng's classification.
- Confirmed abundant blood supply of tumor thrombus using Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).
- The tumor must be surgically resectable.
- ECOG Performance Status 0-2.
- Adequate liver function (Child-Pugh class A)
- Life expectancy ≥ 3 months
- Previous physical ablation is allowed.
- Age 18 to 75 years
- Able to sign and provide written informed consent.
Exclusion Criteria:
- Patients previously took oral molecular targeted drug or received immunotherapy.
- Patients with arteriovenous fistula.
- Severe active infection >grade 2 (except for Hepatitis B and C infection).
- Concomitant malignant tumors in other organs.
- Presence of severe cardiac, lung or kidney disease.
- 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).
Sites / Locations
- Beijing Changgung HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GSMs-TACE+ Surgical Resection Group
GSMs-TACE Group
Arm Description
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.
Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol.
Outcomes
Primary Outcome Measures
Progression Free Survival（PFS）
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
Median Overall Survival (mOS)
Overall Survival
Adverse Events
Full Information
NCT ID
NCT04619342
First Posted
November 3, 2020
Last Updated
November 26, 2020
Sponsor
Beijing Tsinghua Chang Gung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04619342
Brief 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)
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.
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
June 30, 2021 (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 the Treatment of Hepatocellular Carcinoma (HCC) with Type III Portal Vein Tumor Thrombus (PVTT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GSMs-TACE+ Surgical Resection Group
Arm Type
Experimental
Arm Description
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.
Arm Title
GSMs-TACE Group
Arm Type
Active Comparator
Arm Description
Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol.
Intervention Type
Device
Intervention Name(s)
GSMs-TACE
Other Intervention Name(s)
TACE
Intervention Description
TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)
Intervention Type
Procedure
Intervention Name(s)
Surgical Resection
Intervention Description
Surgical Resection of PVTT
Primary Outcome Measure Information:
Title
Progression Free Survival（PFS）
Description
PFS is defined as the time from Day 1 of treatment until the progression of a target lesion or the appearance of new lesions.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Median Overall Survival (mOS)
Time Frame
2 years
Title
Overall Survival
Time Frame
3, 6, 12 and 18 months
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 diagnosis of HCC with PVTT involving the main portal vein, i.e. Type III PVTT according to Cheng's classification.
Confirmed abundant blood supply of tumor thrombus using Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).
The tumor must be surgically resectable.
ECOG Performance Status 0-2.
Adequate liver function (Child-Pugh class A)
Life expectancy ≥ 3 months
Previous physical ablation is allowed.
Age 18 to 75 years
Able to sign and provide written informed consent.
Exclusion Criteria:
Patients previously took oral molecular targeted drug or received immunotherapy.
Patients with arteriovenous fistula.
Severe active infection >grade 2 (except for Hepatitis B and C infection).
Concomitant malignant tumors in other organs.
Presence of severe cardiac, lung or kidney disease.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuewei Zhang
Organizational Affiliation
Beijing Tsinghua Changgeng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Changgung Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuewei Zhang
Phone
00861800115669
Email
zhangyuewei1121@sina.com.cn
12. IPD Sharing Statement
Learn more about this trial
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)
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