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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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ClinicalTrials.gov Identifier: NCT03914352
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jia-zhou Ye, Cancer Hospital of Guangxi Medical University

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.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: PD-1 antibody Procedure: TACE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of Hepatocellular Carcinoma Combined With Portal Vein Thrombus After Hepatic Resection
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PD-1 antibody group
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.
Drug: PD-1 antibody
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.
Other Name: SHR-1210

Active Comparator: Controlled group
In this group entrolled patients were treated with TACE in the 30 days after hepatic resection.
Procedure: TACE
In this group enrolled patients were treated with TACE at the30 days after hepatic resection.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Cumulative survival period after hepatic resection

  2. Disease-free survival [ Time Frame: 5 years ]
    Cumulative none recurrence survival period after hepatic resection



Information from the National Library of Medicine

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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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914352


Contacts
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Contact: Jiazhou Ye, M.D. +86 13367719078 87066160@qq.com
Contact: Lequn Li, M.D. +86 07715310045 lequn_li001@163.com

Locations
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China, Guangxi
Affiliated Tumor Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Jiazhou Ye, M.D.    +86 13367719078    87066160@qq.com   
Contact: Lequn Li, M.D.    +86 07715310045    lequn_li001@163.com   
Sponsors and Collaborators
Cancer Hospital of Guangxi Medical University
Investigators
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Study Chair: Lequn Li, M.D. Cancer Hospital of Guangxi Medical University
Principal Investigator: Jiazhou Ye, M.D. Cancer Hospital of Guangxi Medical University
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Responsible Party: Jia-zhou Ye, Principal investigator, Cancer Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT03914352    
Other Study ID Numbers: CHGuangxiMU
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jia-zhou Ye, Cancer Hospital of Guangxi Medical University:
Hepatocellular carcinoma
Portal vein tumor thrombus
Hepatic resection
Recurrence
PD-1 antibody
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Antibodies
Immunologic Factors
Physiological Effects of Drugs