Status:
UNKNOWN
Camrelizumab Combined With Local Treatment in NSCLC Patients With BM
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
NSCLC Stage IV
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 meta...
Eligibility Criteria
Inclusion
- Age ≥18;
- 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
- 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;
- (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
- The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04291092
Start Date
January 1 2020
End Date
June 30 2023
Last Update
September 10 2021
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022