Clinical trial · Interventional
PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer: A Randomised Controlled Trial
NCT05605613CI-TRIAL-00062089unknownPhase 2 / Phase 3ClinicalTrials.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 randomized controlled trial to determine the efficacy and safety of PD-1 Antibody 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BACE | Device | — | UNRESOLVED |
| PD-1 Antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization
- description
- Treated with BACE and PD-1 antibody as induction therapy during which BACE was performed on the first day and PD-1 antibody was given 3-5 days later, then PD-1 antibody was administered at 200mg Q3W as maintenance therapy.
- interventionNames
- Drug: PD-1 Antibody
- Device: BACE
- type
- ACTIVE_COMPARATOR
- label
- Bronchial Arterial Chemoembolization
- description
- Bronchial artery chemoembolization (BACE) is a technique of drug delivery and embolization performed via injecting anti-tumor drugs with drug carriers and implanting the embolization agents into the tumor feeding artery
- interventionNames
- Device: BACE
Primary outcomes (1)
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 ); Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 4. Adequate hematologic and end-organ function. 5. Expected life span \> 3 months. 6. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells Exclusion Criteria: 1. Prior treatment targeting PD-1, PD-L1 or CTLA-4. 2. Prior therapies of interventional therapy (I seed 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 (0)
Data not yet available
No reference posted for this study.