Camrelizumab Utilization on Patients With Advanced Liver Cancer

April 27, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
          • Xiaogang Zhang, Phd
          • Phone Number: 0086-13891803523
          • Email: zzsghr@qq.com
        • Principal Investigator:
          • Yi Lv, MD,PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Camrelizumab in the treatment of liver cancer
Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min
Other: camrelizumab
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Safety as defined by the NCI CTCAE v5.0
Time Frame: From patients participate in the clinical study to 90 days after the end of treatment
Adverse events as graded by CTCAE v5.0
From patients participate in the clinical study to 90 days after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
1-year, 3-year, 5-year survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Yi Lyu, MD,phD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2020

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJYFY-KRLZ-HCC-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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