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Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hepatectomy alone
Neoadjuvant radiotherapy
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hepatectomy alone

Neoadjuvant radiotherapy plus hepatectomy

Arm Description

Patients in this group will receive hepatectomy alone.

Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.

Outcomes

Primary Outcome Measures

Overall survival
From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.

Secondary Outcome Measures

Recurrence-free survival
From the date of hepatectomy to HCC recurrence or the end of follow-up.

Full Information

First Posted
July 17, 2019
Last Updated
September 1, 2019
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04025437
Brief Title
Neoadjuvant Radiotherapy for HCC Involving Type I PVTT
Official Title
Neoadjuvant Radiotherapy for Patients With Hepatocellular Carcinoma Involving Type I Portal Vein Tumor Thrombus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Neoadjuvant Radiotherapy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hepatectomy alone
Arm Type
Experimental
Arm Description
Patients in this group will receive hepatectomy alone.
Arm Title
Neoadjuvant radiotherapy plus hepatectomy
Arm Type
Active Comparator
Arm Description
Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
Intervention Type
Procedure
Intervention Name(s)
Hepatectomy alone
Intervention Description
Patients in this group will receive hepatectomy alone.
Intervention Type
Radiation
Intervention Name(s)
Neoadjuvant radiotherapy
Intervention Description
Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
Primary Outcome Measure Information:
Title
Overall survival
Description
From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Recurrence-free survival
Description
From the date of hepatectomy to HCC recurrence or the end of follow-up.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Zhong Tang, MD
Organizational Affiliation
Cancer Hospital of Guangxi Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29543938
Citation
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.
Results Reference
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PubMed Identifier
31070690
Citation
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.
Results Reference
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PubMed Identifier
29631810
Citation
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.
Results Reference
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PubMed Identifier
27317960
Citation
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.
Results Reference
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Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

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