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出境医 / 临床实验 / A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi

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

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 Intervention/treatment Phase
Carcinoma, Hepatocellular Radiation: RT Procedure: TACE Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 23, 2019
Estimated Primary Completion Date : April 23, 2021
Estimated Study Completion Date : April 23, 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: TACE Procedure: TACE
transarterial chemoembolization (TACE)
Experimental: TACE+RT Radiation: RT
external- beam radiotherapy (EBRT)

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
Layout table for eligibility information
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<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.
Contacts and Locations

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

Locations
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China, Shanghai
Zhongshan Hosptial Recruiting
Shanghai, Shanghai, China, 200032
Contact: jiazhou hou    +8602164041990 ext +8602164041990    hou.jiazhou@zs-hosptial.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE April 23, 2019
Estimated Primary Completion Date April 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE
  • Radiation: RT
    external- beam radiotherapy (EBRT)
  • Procedure: TACE
    transarterial chemoembolization (TACE)
Study Arms  ICMJE
  • Active Comparator: TACE
    Intervention: Procedure: TACE
  • Experimental: TACE+RT
    Interventions:
    • Radiation: RT
    • Procedure: TACE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2019) 		180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 23, 2022
Estimated Primary Completion Date April 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: jiazhou hou, doctor +86-021-64041990 ext 2764 hou.jiazhou@zs-hosptial.sh.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939845
Other Study ID Numbers  ICMJE PVT/RT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Zhongshan Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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