Carcinoma, Non-Small-Cell LungNCT04825925
Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments
A study testing DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization) in people with Carcinoma, Non-Small-Cell Lung, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a multicenter, prospective, single-arm clinical study to determine the efficacy and safety of Drug-eluting beads bronchial arterial chemoembolization（DEB-BACE） in stage II-III NSCLC patients who failed, refused or ineligible to receive standard treatments Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Oct 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old, of any sex;
- Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）;
- Confirmed TNM stage is II-III of NSCLC;
- Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)；
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
- Life expectancy of > 3 months;
- Patients volunteered to participate in this study and signed informed consent, with good compliance;
Who cannot join
- Patients received interventional therapy (I seeds implantation, Ablation, BACE) before;
- A history combined with other malignant tumors and not cured;
- WBC<3×109/L、LYM<1.5×109/L、NLR≥3、PLT<50×109/L、HGB<90 g/L;
- Insufficient of liver and renal function (Cr>176.8 µmol/L; AST and/or ALT>2 folds of normal value)；
- Combined with uncorrectable coagulation dysfunction or active massive hemoptysis;
- Combined with active affection and need antibiotic treatment;
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- Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms;
- Known to be hypersensitive to contrast agent;
- Pregnant or breastfeeding women;
About this study
This is a multicenter, prospective, single-arm clinical study to determine the efficacy and safety of Drug-eluting beads bronchial arterial chemoembolization（DEB-BACE） in stage II-III NSCLC patients who failed, refused or ineligible to receive standard treatments
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)
- 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.
DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)Device
Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, the Platinum was infused. BAI (Bronchial Arterial Infusion ) chemotherapy was followed by DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with Vinorelbine were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.
| Study group | Role | What they receive |
|---|---|---|
| DEB-BACE | Experimental | Not described Receives: Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization) |
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 DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death
Measured: Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death, up to 36 months
Secondary outcomes (8)
Objective response rate (ORR)
Proportion of patients with reduction in stable in tumor burden of a predefined amount
Measured: 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
Disease control rate (DCR)
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
Measured: 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
Overall survival (OS)
Time from the first DEB-BACE treatment to death from any cause or the end of the study
Measured: Time from the first DEB-BACE treatment to death or up to 36 months
Recurrence rate of hemoptysis
For the NSCLC subjects with hemoptysis, the patients completely or almost completely hemostasis were treated with the first treatment of DEB-BACE. If hemoptysis occurs during follow-up, it is recurrent of hemoptysis
Measured: 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 36 months
Tumor biomarker (CEA, SCC)
Changes of tumor biomarkers
Measured: 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 36 months
Quality of life score (EORTC, QLQ-30)
Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores
Measured: 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 36 months
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score (ECOG PS)
Changes of ECOG PS
Measured: 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 36 months
VAS pain grade
Changes of VAS pain grade
Measured: 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 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Oct 2024 (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.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825925
- Sponsor's protocol ID
- E20210168A
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments
- ClinicalTrials.gov ID
- NCT04825925
- Acronym / sponsor ID
- E20210168A
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Apr 2021 (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 multicenter, prospective, single-arm clinical study to determine the efficacy and safety of Drug-eluting beads bronchial arterial chemoembolization（DEB-BACE） in stage II-III NSCLC patients who failed, refused or ineligible to receive standard treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEB-BACE | Experimental | Device: DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 18 years old, of any sex;
- Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）;
- Confirmed TNM stage is II-III of NSCLC;
- Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)；
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
Key exclusion criteria (9 listed)
- Patients received interventional therapy (I seeds implantation, Ablation, BACE) before;
- A history combined with other malignant tumors and not cured;
- WBC<3×109/L、LYM<1.5×109/L、NLR≥3、PLT<50×109/L、HGB<90 g/L;
- Insufficient of liver and renal function (Cr>176.8 µmol/L; AST and/or ALT>2 folds of normal value)；
- Combined with uncorrectable coagulation dysfunction or active massive hemoptysis;
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 |
|---|---|---|
| DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, the Platinum was infused. BAI (Bronchial Arterial Infusion ) chemotherapy was followed by DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with Vinorelbine were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed. | Device | DEB-BACE |
Primary outcome
Progression-free survival (PFS)
Time frame: Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death, up to 36 months
Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death
8 secondary outcomes
Objective response rate (ORR)
Time frame: 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
Disease control rate (DCR)
Time frame: 1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months
Overall survival (OS)
Time frame: Time from the first DEB-BACE treatment to death or up to 36 months
Recurrence rate of hemoptysis
Time frame: 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 36 months
Tumor biomarker (CEA, SCC)
Time frame: 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 36 months
Quality of life score (EORTC, QLQ-30)
Time frame: 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 36 months
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score (ECOG PS)
Time frame: 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 36 months
VAS pain grade
Time frame: 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 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization) in people with Carcinoma, Non-Small-Cell Lung, run by Tianjin Medical University Cancer Institute and Hospital.
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 7 inclusion and 9 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 12 Apr 2021. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death, up to 36 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 12 Apr 2021.