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Irradiation Stent Placement Plus TACE for HCC and PVTT

NCT03730675 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2018-12-21

No results posted yet for this study

Summary

The study is a multicenter, randomized (1:1), open-label, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of portal irradiation stent placement plus TACE compared to sorafenib plus TACE in patients with advanced HCC accompanied by portal vein tumor thrombosis. Patients will be randomized to receive either portal irradiation stent placement plus TACE(Arm A) or Sorafenib plus TACE (Arm B).

Conditions

Interventions

PROCEDURE

Portal irradiation stent placement

The irradiation portal vein stent was designed as two separate parts that consisted of an outer seeds-loaded-stent and an inner self-expandable metallic stent

PROCEDURE

TACE

TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.

DRUG

Sorafenib

Sorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma.

Sponsors & Collaborators

  • Zhongda Hospital

    lead OTHER

Principal Investigators

  • Gao-Jun Teng, M.D. · Zhongda Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-10
Primary Completion
2021-11-10
Completion
2021-11-10

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730675 on ClinicalTrials.gov