Camrelizumab Utilization on Patients With Advanced Liver Cancer

NCT ID: NCT04487704

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-07
• Study Completion Date: 2025-01-31

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;

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab in the treatment of liver cancer

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

Group Type: OTHER

camrelizumab

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Lyu, MD,phD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xu-Feng Zhang, MD,phD

Role: CONTACT

xfzhang125@126.com

86-029-13359260373

Rui Qu

Role: CONTACT

1289271841@qq.com

86-18681943306

Facility Contacts

Yi Lv, MD,PHD

Role: primary

luyi169@126.com

0086-13991200581

Xiaogang Zhang, Phd

Role: backup

zzsghr@qq.com

0086-13891803523

Other Identifiers

XJYFY-KRLZ-HCC-1

Identifier Type: -

Identifier Source: org_study_id