Carcinoma, Non-Small-Cell LungNCT05248022
Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure
A study testing Drug-eluting beads bronchial arterial chemoembolization and Programmed Cell Death Protein 1 Inhibitor in people with Carcinoma, Non-Small-Cell Lung, run by The Central Hospital of Lishui City.
Trial summary
This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination… 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?
- Drug-eluting beads bronchial arterial chemoembolization and Programmed Cell Death Protein 1 Inhibitor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 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
- Age more than 18 years old, no gender limit.
- According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
- Tumor Node Metastasis (TNM) staging is II-III.
- According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
- Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2.
- Estimated survival time is more than 3 months.
- The patient has signed informed consent.
Who cannot join
- The patient has previously received interventional therapy [iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy], or received immunotherapy during the first-line standard treatment.
- The patient is accompanied by other malignant tumors and had not been cured.
- White blood cell < 3×10*9/L, absolute value of neutrophils < 1.5×10*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count < 50×10*9/L, hemoglobin concentration < 90 g/L.
- Liver and kidney dysfunction (creatinine > 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times the upper limit of normal).
- Uncorrectable coagulopathy or active hemoptysis.
- Patient with active infections requires antibiotic treatment.
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- Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.
- Allergy to contrast agents.
- Women with pregnancy or lactation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure: A Prospective, Multicenter, Randomized, Open, Double-arm Clinical Trial
This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Drug-eluting beads bronchial arterial chemoembolization, Programmed Cell Death Protein 1 Inhibitor
- Keywords
- Non-Small-Cell Lung cancer, Drug-eluting Beads Bronchial Arterial Chemoembolization, PD-1 inhibitor, advanced
- 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.
Drug-eluting beads bronchial arterial chemoembolizationProcedure or surgery
Drug-eluting beads bronchial arterial chemoembolization generally uses platinum-containing two-drug chemotherapy "platinum (cisplatin, carboplatin, nedaplatin) combined treatment, and drug-loaded microspheres can be loaded with vinorelbine, gemcitabine, irinote Kang, raltitrexed. The dose of chemotherapy drugs is set to 75mg/m2 of platinum, and the dose of chemotherapy through catheter infusion is reduced by 25%. The dose of drug-loaded drugs is vinorelbine 25mg/m2, gemcitabine generally 1000mg/m2, irinotecan 80mg/ m2, raltitrexed 4mg. Chemotherapy was perfused first, followed by embolization with drug-loaded microspheres, until the blood flow in the artery supplying the tumor slowed down and approached stagnation. The number of DEB-BACE treatments is determined by the investigator, and is given as needed according to the patient's condition, usually 1-2 times, with an interval of 28±10 days.
Programmed Cell Death Protein 1 InhibitorDrug
Programmed cell death protein 1 inhibitor fixation was treated with sintilimab (Xinda Biopharmaceutical Co., Ltd.). It is administered by intravenous infusion, and the recommended dose is 200 mg, given once every 21 days. The medication will last for two years until disease progression or intolerable toxicity occurs. During immunotherapy, immunosuppressive agents will not be replaced and the dose will not be adjusted.
| Study group | Role | What they receive |
|---|---|---|
| Combination Treatment Group | Experimental | Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment. Receives: Procedure: Drug-eluting beads bronchial arterial chemoembolization; Drug: Programmed Cell Death Protein 1 Inhibitor |
| Single Treatment Group | Active comparator | Only receive drug-eluting beads bronchial arterial chemoembolization treatment. Receives: Procedure: 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
The most common primary endpoint in cancer trials.
Measured: The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.
Secondary outcomes (11)
Overall Survival
The best efficacy endpoint in cancer clinical trials.
Measured: Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.
Time to tumor untreatable progression
End point of antitumor drug trial.
Measured: The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.
Objective Response Rate
Evaluation index of clinical efficacy of anticancer drugs.
Measured: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.
Disease Control Rate
Evaluation index of clinical efficacy of anticancer drugs.
Measured: Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.
Duration of Overall Response
Evaluation index of clinical efficacy of anticancer drugs.
Measured: The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months.
Tumor biomarkers
carcinoembryonic antigen, carbohydrate antigen 125, squamous cell carcinoma, etc
Measured: From pre-procedure to every follow-up time, assessed up to 2 years.
Eastern Cooperative Oncology Group Score
The patient's performance status score is divided into 6 grades. The lowest grade is 0, and the highest grade is 5. The patient's physical state deteriorates as the grade rises.
Measured: From pre-procedure to every follow-up time, assessed up to 2 years.
Recurrence rate of hemoptysis
Hemoptysis occurs again
Measured: From date of randomization to every follow-up time, assessed up to 2 years.
Quality of life Questionare-Core score
The European Organization for Reasearch and Treatment of Cancer Quality of life Questionare-Core score. All items and subscales were converted from 0 to 100, with higher scores indicating better overall quality of life.
Measured: From date of randomization to every follow-up time, assessed up to 2 years.
The incidence of adverse events and serious adverse events
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: From date of randomization to every follow-up time, assessed up to 2 years.
Pain assessment
Visual Analogue Scale/Score.The tool is a 10 cm long roving ruler with 11 scales ranging from 0 to 10. A score of 0 means no pain, and a score of 10 means unbearable pain. The higher the score, the more severe the pain.
Measured: From date of randomization to every follow-up time, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Central Hospital of Lishui City
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Jiangxi Chest Hospital, The First Affiliated Hospital of Zhengzhou University, Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Xihui Ying, MD., Study director, The Central Hospital of Lishui City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248022
- Sponsor's protocol ID
- ZJLS-KLDMIR-21002
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure: A Prospective, Multicenter, Randomized, Open, Double-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT05248022
- Acronym / sponsor ID
- ZJLS-KLDMIR-21002
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-Small-Cell Lung cancer, Drug-eluting Beads Bronchial Arterial Chemoembolization, PD-1 inhibitor, advanced
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- The Central Hospital of Lishui CityUniversity, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Jiangxi Chest Hospital, The First Affiliated Hospital of Zhengzhou University, Zhejiang University
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 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 study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Treatment Group | Experimental | Procedure: Drug-eluting beads bronchial arterial chemoembolization, Drug: Programmed Cell Death Protein 1 InhibitorDrug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment. |
| Single Treatment Group | Active comparator | Procedure: Drug-eluting beads bronchial arterial chemoembolizationOnly receive drug-eluting beads bronchial arterial chemoembolization treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age more than 18 years old, no gender limit.
- According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
- Tumor Node Metastasis (TNM) staging is II-III.
- According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
- Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2.
Key exclusion criteria (9 listed)
- The patient has previously received interventional therapy [iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy], or received immunotherapy during the first-line standard treatment.
- The patient is accompanied by other malignant tumors and had not been cured.
- White blood cell < 3×10*9/L, absolute value of neutrophils < 1.5×10*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count < 50×10*9/L, hemoglobin concentration < 90 g/L.
- Liver and kidney dysfunction (creatinine > 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times the upper limit of normal).
- Uncorrectable coagulopathy or active 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 |
|---|---|---|
| Drug-eluting beads bronchial arterial chemoembolizationDrug-eluting beads bronchial arterial chemoembolization generally uses platinum-containing two-drug chemotherapy "platinum (cisplatin, carboplatin, nedaplatin) combined treatment, and drug-loaded microspheres can be loaded with vinorelbine, gemcitabine, irinote Kang, raltitrexed. The dose of chemotherapy drugs is set to 75mg/m2 of platinum, and the dose of chemotherapy through catheter infusion is reduced by 25%. The dose of drug-loaded drugs is vinorelbine 25mg/m2, gemcitabine generally 1000mg/m2, irinotecan 80mg/ m2, raltitrexed 4mg. Chemotherapy was perfused first, followed by embolization with drug-loaded microspheres, until the blood flow in the artery supplying the tumor slowed down and approached stagnation. The number of DEB-BACE treatments is determined by the investigator, and is given as needed according to the patient's condition, usually 1-2 times, with an interval of 28±10 days. | Procedure or surgery | Combination Treatment Group, Single Treatment Group |
| Programmed Cell Death Protein 1 InhibitorProgrammed cell death protein 1 inhibitor fixation was treated with sintilimab (Xinda Biopharmaceutical Co., Ltd.). It is administered by intravenous infusion, and the recommended dose is 200 mg, given once every 21 days. The medication will last for two years until disease progression or intolerable toxicity occurs. During immunotherapy, immunosuppressive agents will not be replaced and the dose will not be adjusted. | Drug | Combination Treatment Group |
Primary outcome
Progression Free Survival
Time frame: The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.
The most common primary endpoint in cancer trials.
11 secondary outcomes
Overall Survival
Time frame: Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.
Time to tumor untreatable progression
Time frame: The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.
Objective Response Rate
Time frame: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.
Disease Control Rate
Time frame: Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.
Duration of Overall Response
Time frame: The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months.
Tumor biomarkers
Time frame: From pre-procedure to every follow-up time, assessed up to 2 years.
Eastern Cooperative Oncology Group Score
Time frame: From pre-procedure to every follow-up time, assessed up to 2 years.
Recurrence rate of hemoptysis
Time frame: From date of randomization to every follow-up time, assessed up to 2 years.
Quality of life Questionare-Core score
Time frame: From date of randomization to every follow-up time, assessed up to 2 years.
The incidence of adverse events and serious adverse events
Time frame: From date of randomization to every follow-up time, assessed up to 2 years.
Pain assessment
Time frame: From date of randomization to every follow-up time, assessed up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
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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.
Xihui Ying, MD. study director
The Central Hospital of Lishui City
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting beads bronchial arterial chemoembolization and Programmed Cell Death Protein 1 Inhibitor in people with Carcinoma, Non-Small-Cell Lung, run by The Central Hospital of Lishui City.
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 9 Jan 2024. 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?
Contact Jianfei Tu, Dr. (+8613646782878, jianfei1133@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 (time frame: The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 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 9 Jan 2024.