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)

Study Overview
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Brief Summary
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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).

Official Title
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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): A Single Center, Open, Randomized Controlled Trial.

Conditions
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Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)

Intervention / Treatment
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* Device: GSMs-TACE
* Procedure: Surgical Resection


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSMs-TACE+ Surgical Resection Group<br>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<br>* TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)<br>* Other names: TACE;Procedure: Surgical Resection<br>* Surgical Resection of PVTT<br>|
| Active Comparator: GSMs-TACE Group<br>Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol. | Device: GSMs-TACE<br>* TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)<br>* Other names: TACE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival (mOS) |  | 2 years | 
| Overall Survival |  | 3, 6, 12 and 18 months | 
| Adverse Events |  | 6 months |