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Camrelizumab Utilization on Patients With Advanced Liver Cancer

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
camrelizumab
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring RWS, Advanced Liver Cancer, PD-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Camrelizumab in the treatment of liver cancer

Arm Description

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

Outcomes

Primary Outcome Measures

Assess Safety as defined by the NCI CTCAE v5.0
Adverse events as graded by CTCAE v5.0

Secondary Outcome Measures

overall survival
1-year, 3-year, 5-year survival

Full Information

First Posted
May 27, 2020
Last Updated
April 27, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04487704
Brief Title
Camrelizumab Utilization on Patients With Advanced Liver Cancer
Official Title
A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
Keywords
RWS, Advanced Liver Cancer, PD-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab in the treatment of liver cancer
Arm Type
Other
Arm Description
Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min
Intervention Type
Other
Intervention Name(s)
camrelizumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess Safety as defined by the NCI CTCAE v5.0
Description
Adverse events as graded by CTCAE v5.0
Time Frame
From patients participate in the clinical study to 90 days after the end of treatment
Secondary Outcome Measure Information:
Title
overall survival
Description
1-year, 3-year, 5-year survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu-Feng Zhang, MD,phD
Phone
86-029-13359260373
Email
xfzhang125@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Qu
Phone
86-18681943306
Email
1289271841@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Lyu, MD,phD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Lv, MD,PHD
Phone
0086-13991200581
Email
luyi169@126.com
First Name & Middle Initial & Last Name & Degree
Xiaogang Zhang, Phd
Phone
0086-13891803523
Email
zzsghr@qq.com
First Name & Middle Initial & Last Name & Degree
Yi Lv, MD,PHD

12. IPD Sharing Statement

Learn more about this trial

Camrelizumab Utilization on Patients With Advanced Liver Cancer

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