NCT04981665

Brief Summary

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.

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
50

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Nov 2021

Typical duration for phase_2 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

First Submitted

Initial submission to the registry

July 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

July 25, 2021

Last Update Submit

January 4, 2022

Conditions

Hepatocellular CarcinomaAdjuvant Therapy

Keywords

Hepatocellular carcinomaImmunotherapyTransarterial chemoembolizationRecurrenceAntineoplastic Agents, ImmunologicalAntineoplastic Agents

Outcome Measures

Primary Outcomes (1)

  • 2-year Recurrence Free Survival Rate (2-year RFS rate)

    2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.

    Observation period 24 months

Secondary Outcomes (6)

  • Recurrence-Free Survival (RFS)

    24 months

  • Time to recurrence (TTR)

    24 months

  • Overall Survival (OS）

    24 months

  • 1-year RFS rate

    12 months

  • 1-year OS rate/2-year OS rate

    12 months/24 months

  • +1 more secondary outcomes

Study Arms (1)

Postoperative TACE + Tislelizumab 200mg IV Q3W

EXPERIMENTAL

TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.

Drug: TislelizumabDrug: TACE

Interventions

TislelizumabDRUG

Tislelizumab 200mg IV Q3W

Also known as: BGB-A317, Immunotherapy, Anti-PD-1 therapy
Postoperative TACE + Tislelizumab 200mg IV Q3W
TACEDRUG

TACE will be performed after curative resection (4±1w)

Also known as: Transarterial Chemoembolization
Postoperative TACE + Tislelizumab 200mg IV Q3W

Eligibility Criteria

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

You may qualify if:

  • Subjects with a histopathological or cytologically diagnosis of HCC
  • Subjects who have undergone a curative resection
  • High risk for HCC recurrence as protocol defined
  • No previous systematic treatment and locoregional therapy for HCC
  • Child-Pugh Score, Class A
  • ECOG performance status 0 or 1
  • Full recovery from surgical resection
  • Adequate organ function
  • Absence of major macrovascular invasion
  • No extrahepatic spread
  • Life expectancy of at least 6 months

You may not qualify if:

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
  • Evidence of residual, recurrent, or metastatic disease
  • Known history of serious allergy to any monoclonal antibody
  • History of hepatic encephalopathy
  • Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein
  • Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment
  • Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
  • Any active malignancy within 2 years prior to the start of treatment
  • Active or history of autoimmune disease
  • Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

tislelizumabImmunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Central Study Contacts

Tingbo Liang

CONTACT

+8613666676128liangtingbo@zju.edu.cn

Tao Ma

CONTACT

+8613857148997zjumatao@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2021

First Posted

July 29, 2021

Study Start

November 8, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)