Clinical trial NCT05605613: PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
Official title: PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: NSCLC
Keywords: BACE
PD-1 Antibody
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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, promoting the clinical outcomes of patients and providing a palliative treatment option for patients with NSCLC. while the short-term effect of BACE is good, it is easy to relapse and metastasize.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Time from the first BACE treatment to either radiological progression or death or up to 12 months]
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Time Frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
measure: Disease control rate (DCR)
timeFrame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
measure: Overall survival (OS)
timeFrame: 1 years
Other outcomes:
Locations:
city: Guiyang
country: China
facility: People's Hospital of Kaiyang County
state: Guizhou
city: Tangshan
country: China
facility: North China University of Science and Technology Affiliated Hospital
state: Hebei
city: Xingtai
country: China
facility: The Second Affiliated Hospital of Xingtai Medical College
state: Hebei
city: Hebi
country: China
facility: Hebi City Jun County People's Hospital
state: Henan
city: Luohe
country: China
facility: Wuyang County People's Hospital
state: Henan
city: Nanyang
country: China
facility: Dengzhou People's Hospital
state: Henan
city: Puyang
country: China
facility: The Fifth People's Hospital of Puyang City
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Xuhua Duan
role: PRINCIPAL_INVESTIGATOR
References: