Carcinoma, Non-Small Cell LungPhase 2NCT05380271
Efficacy and Safety of DEB-BACE With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC
A Phase 2 study testing sequential DEB-BACE and Arotinib and Tirelizumab and DEB-BACE alone in people with Carcinoma, Non-Small Cell Lung, run by Gang Wu.
Trial summary
This is a prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung
- What is being tested?
- sequential DEB-BACE and Arotinib and Tirelizumab and DEB-BACE alone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Dec 2025
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- Aged >=18 years, <= 85 years;
- Patients with NSCLC diagnosed by imaging and histopathology; TNM stage was III-IV;
- Initial diagnosis, failure of first-line treatment, refusal or inability to perform routine treatment (surgery, radiotherapy and chemotherapy);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Expected survival period ≥ 3 months.
Who cannot join
- Known hypersensitivity to any of the study drugs or excipients;
- Hypertension that is not controlled by the drug;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- WBC count < 3000 /mm3;
- Platlet count < 50000 /mm3;
- Poorly controlled diabetes before enrollment;
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- Clinically significant electrolyte abnormalities judged by researchers;
- Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%;
- Active infection or serious infection that is not controlled by drug;
- History of clinically significant hepatic disease (ALT and/or AST >5 times the upper normal limit);
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Bronchial Arterial Infusion Chemotherapy Combined With Drug Loaded Microspheres Embolization With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC
This is a prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced NSCLC. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- sequential DEB-BACE and Arotinib and Tirelizumab, DEB-BACE alone
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential DEB-BACE and Arotinib and TirelizumabDrug
DEB-BACE+Arotinib + Tirelizumab
DEB-BACE aloneDrug
DEB-BACE alone
| Study group | Role | What they receive |
|---|---|---|
| sequential DEB-BACE and Arotinib and Tirelizumab | Experimental | 1. First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2.
2. Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 ~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery.
3. The third treatment. Arotinib, 8-12mg, oral (stop oral for 1W every 3W).Tirelizumab, 200mg, intravenous drip (every 3W). Receives: Drug: sequential DEB-BACE and Arotinib and Tirelizumab |
| DEB-BACE alone | Active comparator | 1. First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2.
2. Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 ~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery. Receives: Drug: DEB-BACE alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Measured: up to 3 years
Secondary outcomes (2)
ORR
ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Measured: up to 3 years
Overall survival (OS)
The time from recruitment to death due to any cause.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2022 (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 Carcinoma, Non-Small Cell LungStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Wu, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380271
- Sponsor's protocol ID
- IAT-NSCLC-2022-04
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bronchial Arterial Infusion Chemotherapy Combined With Drug Loaded Microspheres Embolization With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC
- ClinicalTrials.gov ID
- NCT05380271
- Acronym / sponsor ID
- IAT-NSCLC-2022-04
- Conditions
- Carcinoma, Non-Small Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gang WuUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 May 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 prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced NSCLC. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential DEB-BACE and Arotinib and Tirelizumab | Experimental | Drug: sequential DEB-BACE and Arotinib and Tirelizumab1. First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 ~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery. 3. The third treatment. Arotinib, 8-12mg, oral (stop oral for 1W every 3W).Tirelizumab, 200mg, intravenous drip (every 3W). |
| DEB-BACE alone | Active comparator | Drug: DEB-BACE alone1. First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2. 2. Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 ~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- Aged >=18 years, <= 85 years;
- Patients with NSCLC diagnosed by imaging and histopathology; TNM stage was III-IV;
- Initial diagnosis, failure of first-line treatment, refusal or inability to perform routine treatment (surgery, radiotherapy and chemotherapy);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
Key exclusion criteria (14 listed)
- Known hypersensitivity to any of the study drugs or excipients;
- Hypertension that is not controlled by the drug;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- WBC count < 3000 /mm3;
- Platlet count < 50000 /mm3;
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 |
|---|---|---|
| sequential DEB-BACE and Arotinib and TirelizumabDEB-BACE+Arotinib + Tirelizumab | Drug | sequential DEB-BACE and Arotinib and Tirelizumab |
| DEB-BACE aloneDEB-BACE alone | Drug | DEB-BACE alone |
Primary outcome
PFS
Time frame: up to 3 years
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
2 secondary outcomes
ORR
Time frame: up to 3 years
Overall survival (OS)
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sequential DEB-BACE and Arotinib and Tirelizumab and DEB-BACE alone in people with Carcinoma, Non-Small Cell Lung, run by Gang Wu.
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 14 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 Gang Wu, M.D. (+86 13938570175, wuganghenan2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 3 years). 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 18 May 2022.