Camrelizumab Utilization on Patients With Advanced Liver Cancer

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487704
• Other study ID #: XJYFY-KRLZ-HCC-1
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2020
• Est. completion date: January 2025

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xu-Feng Zhang, MD,phD
• Phone: 86-029-13359260373
• Email: xfzhang125[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2025
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival	1-year, 3-year, 5-year survival	5 years