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出境医 / 临床实验 / Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

Study Description
Brief Summary:
The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Hepatectomy alone Radiation: Neoadjuvant radiotherapy Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Neoadjuvant Radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Radiotherapy for Patients With Hepatocellular Carcinoma Involving Type I Portal Vein Tumor Thrombus
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Hepatectomy alone
Patients in this group will receive hepatectomy alone.
 Procedure: Hepatectomy alone
Patients in this group will receive hepatectomy alone.
Active Comparator: Neoadjuvant radiotherapy plus hepatectomy
Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
 Radiation: Neoadjuvant radiotherapy
Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
Outcome Measures
Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.


Secondary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 1 year ]
    From the date of hepatectomy to HCC recurrence or the end of follow-up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-75 years;
  • Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus;
  • Child-Pugh A or B (7 score) liver function;
  • With more than 3 months expected survival;
  • The volume of residual liver more than 30%;
  • Patients agree to take part in.

Exclusion Criteria:

  • Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus
  • Previous history of epigastric radiotherapy
  • With extrahepatic metastasis
  • With radiotherapy contraindication;
  • Pregnant woman or sucking period;
  • With repture tumor;
  • With other cancer in previous five years;
  • With chemothrapy, target therapy or immunosuppressive drugs therapy.
Contacts and Locations

Locations
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China, Guangxi
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
Guangxi Medical University
Investigators
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Study Director: Wei-Zhong Tang, MD Cancer Hospital of Guangxi Medical University
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2019) 		Overall survival [ Time Frame: 1 year ]
From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		Overall survival [ Time Frame: 1 year ]
From randomization to death.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2019) 		Recurrence-free survival [ Time Frame: 1 year ]
From the date of hepatectomy to HCC recurrence or the end of follow-up.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		Progression-free survival [ Time Frame: 1 year ]
From randomization to tumor progression.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Radiotherapy for HCC Involving Type I PVTT
Official Title  ICMJE Neoadjuvant Radiotherapy for Patients With Hepatocellular Carcinoma Involving Type I Portal Vein Tumor Thrombus
Brief Summary The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Neoadjuvant Radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Procedure: Hepatectomy alone
    Patients in this group will receive hepatectomy alone.
  • Radiation: Neoadjuvant radiotherapy
    Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
Study Arms  ICMJE
  • Experimental: Hepatectomy alone
    Patients in this group will receive hepatectomy alone.
    Intervention: Procedure: Hepatectomy alone
  • Active Comparator: Neoadjuvant radiotherapy plus hepatectomy
    Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
    Intervention: Radiation: Neoadjuvant radiotherapy
Publications *
  • Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.
  • He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250.
  • Kudo M, Ueshima K, Yokosuka O, Ogasawara S, Obi S, Izumi N, Aikata H, Nagano H, Hatano E, Sasaki Y, Hino K, Kumada T, Yamamoto K, Imai Y, Iwadou S, Ogawa C, Okusaka T, Kanai F, Akazawa K, Yoshimura KI, Johnson P, Arai Y; SILIUS study group. Sorafenib plus low-dose cisplatin and fluorouracil hepatic arterial infusion chemotherapy versus sorafenib alone in patients with advanced hepatocellular carcinoma (SILIUS): a randomised, open label, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):424-432. doi: 10.1016/S2468-1253(18)30078-5. Epub 2018 Apr 7.
  • Li N, Feng S, Xue J, Wei XB, Shi J, Guo WX, Lau WY, Wu MC, Cheng SQ, Meng Y. Hepatocellular carcinoma with main portal vein tumor thrombus: a comparative study comparing hepatectomy with or without neoadjuvant radiotherapy. HPB (Oxford). 2016 Jun;18(6):549-56. doi: 10.1016/j.hpb.2016.04.003. Epub 2016 May 7.

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		214
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-75 years;
  • Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus;
  • Child-Pugh A or B (7 score) liver function;
  • With more than 3 months expected survival;
  • The volume of residual liver more than 30%;
  • Patients agree to take part in.

Exclusion Criteria:

  • Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus
  • Previous history of epigastric radiotherapy
  • With extrahepatic metastasis
  • With radiotherapy contraindication;
  • Pregnant woman or sucking period;
  • With repture tumor;
  • With other cancer in previous five years;
  • With chemothrapy, target therapy or immunosuppressive drugs therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025437
Other Study ID Numbers  ICMJE RT-HCC-PVTT
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
Plan to Share IPD: No
Responsible Party Jian-Hong Zhong, Guangxi Medical University
Study Sponsor  ICMJE Guangxi Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wei-Zhong Tang, MD Cancer Hospital of Guangxi Medical University
PRS Account Guangxi Medical University
Verification Date September 2019

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

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