NCT03914352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

April 10, 2019

Last Update Submit

April 12, 2019

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaPortal vein tumor thrombusHepatic resectionRecurrencePD-1 antibody

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Cumulative survival period after hepatic resection

    5 years

  • Disease-free survival

    Cumulative none recurrence survival period after hepatic resection

    5 years

Study Arms (2)

PD-1 antibody group

EXPERIMENTAL

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

Controlled group

ACTIVE COMPARATOR

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

Procedure: TACE

Interventions

PD-1 antibodyDRUG

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.

Also known as: SHR-1210
PD-1 antibody group
TACEPROCEDURE

In this group enrolled patients were treated with TACE at the30 days after hepatic resection.

Controlled group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

spartalizumabcamrelizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lequn Li, M.D.

    Cancer Hospital of Guangxi Medical University

    STUDY CHAIR

  • Jiazhou Ye, M.D.

    Cancer Hospital of Guangxi Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiazhou Ye, M.D.

CONTACT

+86 1336771907887066160@qq.com

Lequn Li, M.D.

CONTACT

+86 07715310045lequn_li001@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 16, 2019

Study Start

April 1, 2019

Primary Completion

December 30, 2019

Study Completion

January 31, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)