NSCLC Clinical Trial
Official title:
Tislelizumab in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer -- A Single-arm Phase II Trial
Verified date | October 2022 |
Source | The First Affiliated Hospital of Zhengzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-arm phase II trial to determine the efficacy and safety of Tislelizumab in addition to bronchial arterial chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 15, 2023 |
Est. primary completion date | June 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patient age between 18 and 75 2. Signed Informed Consent Form. 3. Confirmed TNM stage is III-? of NSCLC ,and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, Chemotherapy); 4. Eastern Cooperative Oncology Group (ECOG) performance status = 1 5. Adequate hematologic and end-organ function. 6. Expected life span > 3 months. 7. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells Exclusion Criteria: 1. Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4. 2. Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE). 3. Harboring EGFR sensitizing mutation or ALK gene translocation 4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline. 5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment. 6. Symptomatic central nervous system metastasis 7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment. 8. Prior allogeneic stem cell transplantation or organ transplantation 9. Active autoimmune diseases or history of autoimmune diseases that may relapse. 10. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications 11. Known to be hypersensitive to contrast agent; 12. Pregnant or breastfeeding women; 13. Other protocol defined Inclusion/Exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Hennan |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Zhengzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) | Time from the first BACE treatment to either radiological progression or death | Time from the first BACE treatment to either radiological progression or death or up to 12 months | |
Secondary | Objective response rate (ORR) | Proportion of patients with reduction in stable in tumor burden of a predefined amount | 2, 4, 6 months after the first BACE treatment, up to death or 12 months | |
Secondary | Disease control rate (DCR) | Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount | 2, 4, 6 months after the first BACE treatment, up to death or 12 months | |
Secondary | Overall survival (OS) | Time from the first BACE treatment to death from any cause or the end of the study | 1 years or more | |
Secondary | Quality of life score (EORTC, QLQ-30) | Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores | Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 12 months |
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