Status:
RECRUITING
Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Lung Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with p...
Eligibility Criteria
Inclusion
- Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
- Patients with brain metastases confirmed by imaging;
- Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
- ECOG PS: 0-1;
- Measurable target lesions outside the skull (as per RECIST 1.1);
- Life expectancy greater than 3 months;
Exclusion
- Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
- The patient had received systemic chemotherapy as advanced treatment;
- Patients with EGFR mutation or ALK gene translocation;
- The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
- Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06056115
Start Date
May 1 2023
End Date
December 12 2026
Last Update
September 28 2023
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
Shijiazhuang, Hebei, China