Clinical trial · Interventional
Tislelizumab in Addition to BACE in Patients with NSCLC
Tislelizumab in Addition to Bronchial Arterial Chemoembolization in Patients with Non-Small-Cell Lung Cancer -- a Single-arm Phase II Trial
NCT05058560CI-TRIAL-00087150completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BACE+Tislelizumab
- description
- BACE was performed on the first day of the first cycle, and the first 200 mg of tislelizumab was given 3-5 days later.
- interventionNames
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Time from the first BACE treatment to either radiological progression or death or up to 12 months
- description
- Time from the first BACE treatment to either radiological progression or death
Secondary outcomes (4)
- measure
- Objective response rate (ORR)
- timeFrame
- 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age between 18 and 75 2. Signed Informed Consent Form. 3. Confirmed TNM stage is III-Ⅳ 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
References
Publications (1)
- DERIVEDLiang C, Han D, Li H, Wang M, Kuang D, Chen H, Miao H, Chen P, Lu H, Jiao P, Ren J, Han X, Li F, Duan X. Bronchial Arterial Chemoembolization Combined with Tislelizumab for Non-Small Cell Lung Cancer: An Exploratory, Prospective, Single-Arm, Phase II Trial. J Vasc Interv Radiol. 2026 Apr;37(4):108001. doi: 10.1016/j.jvir.2026.108001. Epub 2026 Jan 16. PMID 41548595