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NCT05058560CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 13 Mar 2025

Brief summary (registry, in English)

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 (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (actual)
First submitted
31 Aug 2021
Start date
Dec 2021
Primary completion date
Feb 2025
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Diseases
Lung cancer
NCT number
NCT05058560

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 30
  • From Dec 2021 to the primary completion date, Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.
  • Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).
  • Prior allogeneic stem cell transplantation or organ transplantation
  • With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications

Other illness

  • History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
  • Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
  • Active autoimmune diseases or history of autoimmune diseases that may relapse.

Lab values

  • Harboring EGFR sensitizing mutation or ALK gene translocation

Other

  • With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
  • Symptomatic central nervous system metastasis
  • Known to be hypersensitive to contrast agent;
  • Pregnant or breastfeeding women;
  • Other protocol defined Inclusion/Exclusion criteria may apply

Who the study is looking for

  • Patient age between 18 and 75
  • Signed Informed Consent Form.
  • 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
  • Adequate hematologic and end-organ function.
  • Expected life span \> 3 months.
  • Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.