Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital

Criteria

Inclusion Criteria:

1. Age ≥18;

2. ECOG is 0-1;

3. Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;

4. 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;

5. According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;

6. Sign informed consent and agree to collect the clinical efficacy and information of the patient.

Exclusion Criteria:

1. Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)

2. Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)

3. Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;

4. Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);

5. History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;

6. Patients with interstitial lung disease or previous history of interstitial pneumonia;

7. Having a history of substance abuse and unable to abstain from it or having mental disorders;

8. who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;

9. Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;

10. 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;

11. (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;

12. The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.