NCT04487704

Brief Summary

To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer

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
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

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 7, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

May 27, 2020

Last Update Submit

April 27, 2022

Conditions

Advanced Hepatocellular Carcinoma

Keywords

RWSAdvanced Liver CancerPD-1

Outcome Measures

Primary Outcomes (1)

  • Assess Safety as defined by the NCI CTCAE v5.0

    Adverse events as graded by CTCAE v5.0

    From patients participate in the clinical study to 90 days after the end of treatment

Secondary Outcomes (1)

  • overall survival

    5 years

Study Arms (1)

Camrelizumab in the treatment of liver cancer

OTHER

Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min

Other: camrelizumab

Interventions

camrelizumabOTHER

camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG

Camrelizumab in the treatment of liver cancer

Eligibility Criteria

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

You may qualify if:

  • years old or more;
  • For both men and women;
  • Patients with advanced liver cancer confirmed by histopathology or cytology; .Volunteer to join the study, sign the informed consent, good compliance, and cooperate with the follow-up.

You may not qualify if:

  • A known allergy to the study drug or any of its excipients; Or had a severe allergic reaction to other monoclonal antibodies;
  • Patients who are ready for or have previously received an organ or allogeneic bone marrow transplant;
  • Pregnant or lactating women;
  • According to the judgment of the researcher, the patients should not be included in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

MeSH Terms

Interventions

camrelizumab

Study Officials

  • Yi Lyu, MD,phD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu-Feng Zhang, MD,phD

CONTACT

86-029-13359260373xfzhang125@126.com

Rui Qu

CONTACT

86-186819433061289271841@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

July 27, 2020

Study Start

April 7, 2020

Primary Completion

January 1, 2023

Study Completion

January 1, 2025

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

CN(1)