Tislelizumab in Addition to BACE in Patients with NSCLC

NCT05058560 | Completed Phase 2

• 1 other identifier: 20210831
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

NSCLC

Keywords

BACE; PD-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective response rate (ORR)

  2, 4, 6 months after the first BACE treatment, up to death or 12 months

• Disease control rate (DCR)

  2, 4, 6 months after the first BACE treatment, up to death or 12 months

• Overall survival (OS)

  1 years or more

• Quality of life score (EORTC, QLQ-30)

  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

Study Arms (1)

BACE+Tislelizumab

EXPERIMENTAL

BACE was performed on the first day of the first cycle, and the first 200 mg of tislelizumab was given 3-5 days later.

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

tislelizumab, 200 mg IV Q3W, up to one year.

Also known as: Bronchial artery chemoembolization (BACE)

BACE+Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.
• Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).
• Harboring EGFR sensitizing mutation or ALK gene translocation
• History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
• With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
• Symptomatic central nervous system metastasis
• Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
• Prior allogeneic stem cell transplantation or organ transplantation
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications
• Known to be hypersensitive to contrast agent;
• Pregnant or breastfeeding women;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Hennan, 450000, China

Location

MeSH Terms

Interventions

tislelizumab

Study Officials

• Xuhua Duan

  Zhengzhou University - First Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 27, 2021
• Study Start: December 1, 2021
• Primary Completion: February 4, 2025
• Study Completion: February 15, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (1)