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)

Beijing Tsinghua Chang Gung Hospital

Status: Unknown

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

Treatments: Device: GSMs-TACE; Procedure: Surgical Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04619342

20304-0-01

Details and patient eligibility

About

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).

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

GSMs-TACE+ Surgical Resection Group

Experimental group

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.

Treatment:

Procedure: Surgical Resection

Device: GSMs-TACE

GSMs-TACE Group

Active Comparator group

Description:

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

Treatment:

Device: GSMs-TACE