A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of HCC Combined With PVTT After Hepatic Resection
NCT ID: NCT03914352
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-04-01
2020-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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.
Controlled group
In this group entrolled patients were treated with TACE in the 30 days after hepatic resection.
TACE
In this group enrolled patients were treated with TACE at the30 days after hepatic resection.
Interventions
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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.
TACE
In this group enrolled patients were treated with TACE at the30 days after hepatic resection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of intra or extra-hepatic recurrence
* Child-pugh grade C liver function
* Combined with other organ dysfunction
18 Years
75 Years
ALL
Yes
Sponsors
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Cancer Hospital of Guangxi Medical University
OTHER
Responsible Party
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Jia-zhou Ye
Principal investigator
Principal Investigators
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Lequn Li, M.D.
Role: STUDY_CHAIR
Cancer Hospital of Guangxi Medical University
Jiazhou Ye, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital of Guangxi Medical University
Locations
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Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHGuangxiMU
Identifier Type: -
Identifier Source: org_study_id
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