Camrelizumab Combined With Chemotherapy and Local Treatment in Non-small Cell Lung Cancer Patients With Brain Metastasis, a Single-arm, Multi-center, Open-labeled Phase II Clinical Trial

Zhejiang Cancer Hospital1 site in 1 country63 target enrollmentJanuary 1, 2020

ConditionsNSCLC Stage IV Brain Metastases Immunotherapy

InterventionsImmunotherapy WBRT Chemotherapy

DrugsImmunotherapy Chemotherapy

Overview

Phase: Phase 2
Intervention: Immunotherapy
Conditions: NSCLC Stage IV
Sponsor: Zhejiang Cancer Hospital
Enrollment: 63
Locations: 1
Primary Endpoint: 6 month progression-free survival rate
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.

Detailed Description

To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .

Registry

clinicaltrials.gov

Start Date

January 1, 2020

End Date

June 30, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Principal Investigator

GongLei

Professor

Zhejiang Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•ECOG is 0-1;
•Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
•The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;
•According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
•Sign informed consent and agree to collect the clinical efficacy and information of the patient.

Exclusion Criteria

•Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
•Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
•Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
•Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
•History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
•Patients with interstitial lung disease or previous history of interstitial pneumonia;
•Having a history of substance abuse and unable to abstain from it or having mental disorders;
•who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
•Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
•previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;