NCT03859128

Brief Summary

This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.

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
402

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2019

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

February 18, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 5, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

4.1 years

First QC Date

February 18, 2019

Last Update Submit

March 28, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • BICR-RFS

    Defined as the time from randomization to the first documented disease recurrence or death.

    Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis)

Secondary Outcomes (8)

  • Investigator-RFS

    up to 44 months

  • 12-month recurrence-free survival rate (RFS12)

    up to 44 months

  • 24-month recurrence-free survival rate (RFS24)

    up to 44 months

  • Time to recurrence (TTR)

    up to 44 months

  • Time to local recurrence (TTLR)

    up to 44 months

  • +3 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

TORIPALIMAB 240mg ,Q3W, up to 16 cycles

Biological: TORIPALIMAB INJECTION(JS001 )

Group B

PLACEBO COMPARATOR

Placebo 240mg Q3W, up to 16 cycles

Biological: TORIPALIMAB INJECTION(JS001 )

Interventions

TORIPALIMAB INJECTION(JS001 )BIOLOGICAL

Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
  • BICR confirmed no resdual tumor lesions are detected in liver;
  • Child-Puch score, Class A;
  • ECOG score is 0;

You may not qualify if:

  • Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
  • Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
  • With symptoms of central nervous system metastasis;
  • With any history of active autoimmune disease or autoimmune disease;
  • Known liver diseases with clinical significance;
  • Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

March 1, 2019

Study Start

March 5, 2019

Primary Completion

April 18, 2023

Study Completion

August 1, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

CN(1)