Camrelizumab Utilization on Patients With Advanced Liver Cancer

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04487704

Collaborator

(none)

1,000

Enrollment

Location

Arm

56.8

Anticipated Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Hepatocellular Carcinoma	Other: camrelizumab	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 7, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Assess Safety as defined by the NCI CTCAE v5.0 [From patients participate in the clinical study to 90 days after the end of treatment]
Adverse events as graded by CTCAE v5.0

Secondary Outcome Measures

overall survival [5 years]
1-year, 3-year, 5-year survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT04487704

Other Study ID Numbers:

XJYFY-KRLZ-HCC-1

First Posted:

Jul 27, 2020

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University

RWS

Advanced Liver Cancer

PD-1

Additional relevant MeSH terms:

Liver Neoplasms

Study Results

No Results Posted as of Apr 29, 2022