A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi

May 4, 2019 updated by: Shanghai Zhongshan Hospital

A Prospective, Randomized, Multicenter Study of Comparison of Transarterial Chemoembolization (TACE) Combination With and Without External- Beam Radiotherapy (EBRT) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi

The 1-year and 2-year overall survival rate (OS), local control rate (FFLP), disease-free progression time (PFS), and side effects were compared in patients with hepatocellular carcinoma limited to intrahepatic unresectable hepatocellular carcinoma with portal venous thrombosis combined with or without external radiotherapy, providing a basis for the development of relevant guidelines.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. confirmed by pathology or met the clinical diagnostic criteria of hepatocellular carcinoma.
  2. after the joint consultation between the interventional department and the radiotherapy department, the patients who were considered to be interventional were considered. Meeting the following criteria: the tumor was confined to the liver (meeting the liver tolerance dose), and was diagnosed as type II or type III portal vein tumor thrombi according to chang's classification criteria, without extrahepatic metastasis. Number of tumors in liver parenchyma: less than or equal to 3. The main portal vein is not completely blocked or the compensatory collateral vessels of the portal vein are abundant although it is completely blocked.
  3. patients who meet all the following criteria: Child-Pugh score ≤7, PLT>30×109/L, WBC>3×10^9/L/ANC>1.5×10^9/L,Hb>90g/L, Cr<2.0mg/dL.
  4. ECOG score 0-2 points.
  5. estimated survival time > 3 months.
  6. age > 18.
  7. sign the informed consent.

Exclusion Criteria:

  1. patients with the following condition: the number of intrahepatic tumors >3 or total tumor diameter>15cm.
  2. patients with signs of extrahepatic metastasis, including but not limited to inferior vena cava carcinoma thrombus, bone metastasis, brain metastasis or regional lymph node metastasis.
  3. patients with West Haven standard grade III/IV hepatic encephalopathy or ascites.
  4. patients with a history of malignancy other than primary HCC, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
  5. patients with a history of upper abdominal radiotherapy.
  6. in the radiotherapy plan, patients who failed to follow the radiation dose limit of important organs, including those whose normal liver tissue was less than 700 ml in the radiotherapy plan.
  7. screening patients who have received other study drugs within 4 weeks prior to the start of the visit.
  8. screening: patients who had received treatment for other local or systemic hepatocellular carcinoma within 4 weeks before the visit.
  9. patients with significant concurrent diseases.
  10. lactating or pregnant female patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TACE
Procedure: TACE
transarterial chemoembolization (TACE)
EXPERIMENTAL: TACE+RT
Procedure: TACE
transarterial chemoembolization (TACE)
Radiation: RT
external- beam radiotherapy (EBRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
overall survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2019

Primary Completion (ANTICIPATED)

April 23, 2021

Study Completion (ANTICIPATED)

April 23, 2022

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

May 4, 2019

First Posted (ACTUAL)

May 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT/RT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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