NSCLCPhase 2/3NCT05605613
PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
A Phase 2/3 study testing PD-1 Antibody and BACE in people with NSCLC, run by Xuhua Duan at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- PD-1 Antibody and BACE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesChina
- Study dates
- 29 Oct 2022to 1 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior treatment targeting PD-1, PD-L1 or CTLA-4.
- Prior therapies of interventional therapy (I seed 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
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- 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;
- Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
People's Hospital of Kaiyang County
Guiyang, Guizhou
ShengHai Liang
- Recruiting
Hebi City Jun County People's Hospital
Hebi, Henan
Yanbing Zhang
- Recruiting
Wuyang County People's Hospital
Luohe, Henan
Chenguang Pang
- Recruiting
Dengzhou People's Hospital
Nanyang, Henan
Yanliang Li
- Recruiting
The Fifth People's Hospital of Puyang City
Puyang, Henan
Liuan Sun
- Recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei
Shiqi Zhou
- Recruiting
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei
Shusen Li
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Xuhua Duan, +8613523402912, xuhuaduan@163.com
About this study
Official title: PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer: A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- NSCLC
- Being tested
- PD-1 Antibody, BACE
- Keywords
- BACE, PD-1 Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 AntibodyDrug
Also called PD-1 Inhibitors
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1
BACEDevice
Bronchial Arterial Chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization | Experimental | 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. Receives: Drug: PD-1 Antibody; Device: BACE |
| Bronchial Arterial Chemoembolization | Active comparator | 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 Receives: Device: BACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from the first BACE treatment to either radiological progression or death
Measured: Time from the first BACE treatment to either radiological progression or death or up to 12 months]
Secondary outcomes (3)
Objective response rate (ORR)
Proportion of patients with reduction in stable in tumor burden of a predefined amount
Measured: Time Frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Disease control rate (DCR)
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
Measured: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Overall survival (OS)
ime from the first BACE treatment to death from any cause or the end of the study
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start29 Oct 2022
- Primary completion15 Nov 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuhua Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuhua Duan, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xuhua Duan, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605613
- Sponsor's protocol ID
- 20221030
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05605613
- Acronym / sponsor ID
- 20221030
- Conditions
- NSCLC
- Keywords
- BACE, PD-1 Antibody
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xuhua DuanUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization | Experimental | Drug: PD-1 Antibody, Device: BACETreated 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. |
| Bronchial Arterial Chemoembolization | Active comparator | Device: BACEBronchial 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- Prior treatment targeting PD-1, PD-L1 or CTLA-4.
- Prior therapies of interventional therapy (I seed 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 AntibodyAlso: PD-1 InhibitorsPD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1 | Drug | PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization |
| BACEBronchial Arterial Chemoembolization | Device | Bronchial Arterial Chemoembolization, PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization |
Primary outcome
Progression-free survival (PFS)
Time frame: Time from the first BACE treatment to either radiological progression or death or up to 12 months]
Time from the first BACE treatment to either radiological progression or death
3 secondary outcomes
Objective response rate (ORR)
Time frame: Time Frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Disease control rate (DCR)
Time frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Overall survival (OS)
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuhua Duan principal investigator
The First Affiliated Hospital of Zhengzhou University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PD-1 Antibody and BACE in people with NSCLC, run by Xuhua Duan at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XuHua Duan (+8613523402912, xuhuaduan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time from the first BACE treatment to either radiological progression or death or up to 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.