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A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of HCC Combined With PVTT After Hepatic Resection

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PD-1 antibody
TACE
Sponsored by
Cancer Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Portal vein tumor thrombus, Hepatic resection, Recurrence, PD-1 antibody

Eligibility Criteria

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

Inclusion Criteria:

  • HCC comfirmed by postoperative histology examination
  • PVTT comfirmed by postoperative histology examination
  • None other type of malignant tumors
  • None intra or extra-hepatic recurrence postoperative adjuvant therapy
  • Child-pugh grade A or B liver function
  • None other organ dysfunction

Exclusion Criteria:

  • Combined with other type of malignant tumors
  • Presence of intra or extra-hepatic recurrence
  • Child-pugh grade C liver function
  • Combined with other organ dysfunction

Sites / Locations

  • Affiliated Tumor Hospital of Guangxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PD-1 antibody group

Controlled group

Arm Description

In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days.

In this group entrolled patients were treated with TACE in the 30 days after hepatic resection.

Outcomes

Primary Outcome Measures

Overall survival
Cumulative survival period after hepatic resection
Disease-free survival
Cumulative none recurrence survival period after hepatic resection

Secondary Outcome Measures

Full Information

First Posted
April 10, 2019
Last Updated
April 12, 2019
Sponsor
Cancer Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03914352
Brief Title
A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of HCC Combined With PVTT After Hepatic Resection
Official Title
A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of Hepatocellular Carcinoma Combined With Portal Vein Thrombus After Hepatic Resection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hepatic resection is the most effective curative treatment for resectable HCC, whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. PVTT has been certified as an independent risk of early recurrence. Although TACE has been used to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the STORM trial shows that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need. At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.
Detailed Description
Hepatic resection is the most effective curative treatment for resectable hepatocellular carcinoma (HCC), whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. Portal vein tumor thrombus (PVTT) has been certified as an independent risk of early recurrence (≤2years after hepatic resection). Although Transarterial Chemoembolization (TACE) has been used as an effective local adjuvant treatment to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the double blind randomized STORM trial shows a negative result that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need. At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Portal vein tumor thrombus, Hepatic resection, Recurrence, PD-1 antibody

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD-1 antibody group
Arm Type
Experimental
Arm Description
In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days.
Arm Title
Controlled group
Arm Type
Active Comparator
Arm Description
In this group entrolled patients were treated with TACE in the 30 days after hepatic resection.
Intervention Type
Drug
Intervention Name(s)
PD-1 antibody
Other Intervention Name(s)
SHR-1210
Intervention Description
In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days.
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
In this group enrolled patients were treated with TACE at the30 days after hepatic resection.
Primary Outcome Measure Information:
Title
Overall survival
Description
Cumulative survival period after hepatic resection
Time Frame
5 years
Title
Disease-free survival
Description
Cumulative none recurrence survival period after hepatic resection
Time Frame
5 years

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: HCC comfirmed by postoperative histology examination PVTT comfirmed by postoperative histology examination None other type of malignant tumors None intra or extra-hepatic recurrence postoperative adjuvant therapy Child-pugh grade A or B liver function None other organ dysfunction Exclusion Criteria: Combined with other type of malignant tumors Presence of intra or extra-hepatic recurrence Child-pugh grade C liver function Combined with other organ dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiazhou Ye, M.D.
Phone
+86 13367719078
Email
87066160@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lequn Li, M.D.
Phone
+86 07715310045
Email
lequn_li001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lequn Li, M.D.
Organizational Affiliation
Cancer Hospital of Guangxi Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jiazhou Ye, M.D.
Organizational Affiliation
Cancer Hospital of Guangxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiazhou Ye, M.D.
Phone
+86 13367719078
Email
87066160@qq.com
First Name & Middle Initial & Last Name & Degree
Lequn Li, M.D.
Phone
+86 07715310045
Email
lequn_li001@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of HCC Combined With PVTT After Hepatic Resection

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