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)

Not Applicable

• Conditions: Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)
• Interventions: Device: GSMs-TACE; Procedure: Surgical Resection

• Registration Number: NCT04619342
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-30
• Status Verified: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-06
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30
• Primary Completion: 2021-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSMs-TACE+ Surgical Resection Group	Surgical Resection	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+ Surgical Resection Group	GSMs-TACE	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 Group	GSMs-TACE	Patients will receive TACE using epirubicin and GSMs (150-350μm or 350-560μm), as specified per protocol.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall Survival	3, 6, 12 and 18 months
Adverse Events	6 months
Median Overall Survival (mOS)	2 years

Trial Locations

Locations (1)

Beijing Changgung Hospital; 🇨🇳 Beijing, China