Camrelizumab Utilization on Patients With Advanced Liver Cancer

Not Applicable

Recruiting

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Other: camrelizumab

• Registration Number: NCT04487704
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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;

Study Timeline

• Study Start: 2020-04-07
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-29
• Primary Completion: 2023-01-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab in the treatment of liver cancer	camrelizumab	Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
overall survival	5 years	1-year, 3-year, 5-year survival

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China