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)

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04619342

Enrollment

Registered

2020-11-06

Start date

2020-10-30

Completion date

2022-12-31

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

DEVICEGSMs-TACE

TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)

PROCEDURESurgical Resection

Surgical Resection of PVTT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactYuewei Zhang

zhangyuewei1121@sina.com.cn00861800115669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026