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)

  • STATUS
    Recruiting
  • days left to enroll
    36
  • participants needed
    98
  • sponsor
    Beijing Tsinghua Chang Gung Hospital
Updated on 27 January 2021

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).

Details
Condition Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT), Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT), Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT), Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT)
Treatment Surgical Resection, GSMs-TACE
Clinical Study IdentifierNCT04619342
SponsorBeijing Tsinghua Chang Gung Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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)
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