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

April 12, 2019 updated by: Jia-zhou Ye, Cancer Hospital of Guangxi Medical University

A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of Hepatocellular Carcinoma Combined With Portal Vein Thrombus After Hepatic Resection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Affiliated Tumor Hospital of Guangxi Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Cumulative survival period after hepatic resection
5 years
Disease-free survival
Time Frame: 5 years
Cumulative none recurrence survival period after hepatic resection
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Hospital of Guangxi Medical University

Investigators

  • Study Chair: Lequn Li, M.D., Cancer Hospital of Guangxi Medical University
  • Principal Investigator: Jiazhou Ye, M.D., Cancer Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

January 31, 2020

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHGuangxiMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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