PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
NCT ID: NCT05605613
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2022-10-29
2025-12-01
Brief Summary
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Detailed Description
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The rapid development of immunotherapy checkpoint inhibitors represented by PD-1/L1 monoclonal antibody has changed the treatment pattern of NSCLC. The publication of early research data repeatedly verified the long-term survival benefit characteristics of PD-1/L1 in NSCLC.
Based on this research and clinical practice, we designed this 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization
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.
PD-1 Antibody
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1
BACE
Bronchial Arterial Chemoembolization
Bronchial Arterial Chemoembolization
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
BACE
Bronchial Arterial Chemoembolization
Interventions
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PD-1 Antibody
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1
BACE
Bronchial Arterial Chemoembolization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
No
Sponsors
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Xuhua Duan
OTHER
Responsible Party
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Xuhua Duan
Associate Professor
Principal Investigators
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Xuhua Duan
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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People's Hospital of Kaiyang County
Guiyang, Guizhou, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Hebi City Jun County People's Hospital
Hebi, Henan, China
Wuyang County People's Hospital
Luohe, Henan, China
Dengzhou People's Hospital
Nanyang, Henan, China
The Fifth People's Hospital of Puyang City
Puyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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ShengHai Liang
Role: primary
Shiqi Zhou
Role: primary
Shusen Li
Role: primary
Yanbing Zhang
Role: primary
Chenguang Pang
Role: primary
Yanliang Li
Role: primary
Liuan Sun
Role: primary
Other Identifiers
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20221030
Identifier Type: -
Identifier Source: org_study_id
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