A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
NCT ID: NCT03939845
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2019-04-23
2022-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TACE
TACE
transarterial chemoembolization (TACE)
TACE+RT
RT
external- beam radiotherapy (EBRT)
TACE
transarterial chemoembolization (TACE)
Interventions
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RT
external- beam radiotherapy (EBRT)
TACE
transarterial chemoembolization (TACE)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Locations
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Zhongshan Hosptial
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PVT/RT
Identifier Type: -
Identifier Source: org_study_id
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