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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03939845

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Carcinoma, Hepatocellular
  • Intervention/Treatment: Procedure: TACE
    Radiation: RT
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 180 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2022
Arms and interventions
Arm Intervention/treatment
Experimental: TACE+RT
Radiation: RT
external- beam radiotherapy (EBRT)

Procedure: TACE
transarterial chemoembolization (TACE)
Active Comparator: TACE
Procedure: TACE
transarterial chemoembolization (TACE)
Outcome Measures
  • Primary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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 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.

Contacts and Locations
Contacts

Contact: jiazhou hou, doctor +86-021-64041990 ext 2764 hou.jiazhou@zs-hosptial.sh.cn

Locations

China, Shanghai
Zhongshan Hosptial
Shanghai

Sponsors and Collaborators

Shanghai Zhongshan Hospital

More Information
  • Responsible Party: Shanghai Zhongshan Hospital
  • ClinicalTrials.gov Identifier: NCT03939845 History of Changes
  • Other Study ID Numbers: PVT/RT
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma Carcinoma, Hepatocellular