CarcinomaNCT06364046
Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC
A study testing Drug-eluting beads bronchial arterial chemoembolization, Serplulimab and Intravenous chemotherapy in people with Carcinoma and Small Cell Lung Cancer, run by The Central Hospital of Lishui City at 1 site in China.
Trial summary
This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Small Cell Lung Cancer
- What is being tested?
- Drug-eluting beads bronchial arterial chemoembolization, Serplulimab and Intravenous chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2025
- 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, regardless of gender;
- SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
- TNM stage II-IV;
- ECOG PS score ≤2;
- Predicted survival time more than 3 months;
- Provision of signed informed consent.
Who cannot join
- Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
- Concurrent presence of other incurable malignant tumors;
- White blood cell count less than 3×10^9/L, neutrophil absolute count less than 1.5×10^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10^9/L, hemoglobin concentration less than 90 g/L;
- Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
- Uncorrectable coagulopathy or concurrent active hemoptysis;
- Complicated with active infection requiring antibiotic treatment;
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- Uncontrolled hypertension, diabetes, or cardiovascular disease;
- Allergy to contrast agents;
- Women who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC:A Prospective, Single-center, Randomized, Open, Double-arm Clinical Trial
This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.
- Conditions
- Carcinoma, Small Cell Lung Cancer
- Being tested
- Drug-eluting beads bronchial arterial chemoembolization, Serplulimab, Intravenous chemotherapy
- Keywords
- Small Cell Lung Cancer, Programmed Cell Death Protein 1 Inhibitor, Serplulimab, Drug-eluting beads bronchial arterial chemoembolization
- Medical subject headings
- Carcinoma, Small Cell Lung Carcinoma
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 are loaded with irinotecan. 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 irinotecan 80mg/ m2. 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.
SerplulimabDrug
Programmed cell death protein 1 inhibitor fixation was treated with serplulimab (Fuhong Hanlin 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.
Intravenous chemotherapyProcedure or surgery
Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab | Experimental | Not described Receives: Procedure: Drug-eluting beads bronchial arterial chemoembolization; Drug: Serplulimab |
| Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab | Active comparator | Not described Receives: Drug: Serplulimab; Procedure: Intravenous chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 at 1 month, 3 months, and 6 months , assessed up to 12 months
Secondary outcomes (14)
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
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.
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.
Tumor biomarkers
squamous cell carcinoma
Measured: From pre-procedure to every follow-up time, assessed up to 2 years.
Tumor biomarkers
carbohydrate antigen 125
Measured: From pre-procedure to every follow-up time, assessed up to 2 years.
Tumor biomarkers
carcinoembryonic antigen
Measured: 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.
Measured: 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,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: Time Frame: 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 posted15 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Central Hospital of Lishui City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linqiang Lai, MD., Study director, The Central Hospital of Lishui City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364046
- Sponsor's protocol ID
- ZJLS-KLDMIR-22006
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2024
- Last updated
- 15 Apr 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC:A Prospective, Single-center, Randomized, Open, Double-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06364046
- Acronym / sponsor ID
- ZJLS-KLDMIR-22006
- Conditions
- Carcinoma, Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer, Programmed Cell Death Protein 1 Inhibitor, Serplulimab, Drug-eluting beads bronchial arterial chemoembolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The Central Hospital of Lishui CityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Apr 2024 (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 project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab | Experimental | Procedure: Drug-eluting beads bronchial arterial chemoembolization, Drug: Serplulimab |
| Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab | Active comparator | Drug: Serplulimab, Procedure: Intravenous chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age more than 18 years old, regardless of gender;
- SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
- TNM stage II-IV;
- ECOG PS score ≤2;
- Predicted survival time more than 3 months;
Key exclusion criteria (9 listed)
- Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
- Concurrent presence of other incurable malignant tumors;
- White blood cell count less than 3×10^9/L, neutrophil absolute count less than 1.5×10^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10^9/L, hemoglobin concentration less than 90 g/L;
- Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
- Uncorrectable coagulopathy or concurrent 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 are loaded with irinotecan. 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 irinotecan 80mg/ m2. 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 | Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab |
| SerplulimabProgrammed cell death protein 1 inhibitor fixation was treated with serplulimab (Fuhong Hanlin 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 | Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab, Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab |
| Intravenous chemotherapyIntravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days | Procedure or surgery | Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab |
Primary outcome
Objective response rate
Time frame: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria at 1 month, 3 months, and 6 months , assessed up to 12 months
Evaluation index of clinical efficacy of anticancer drugs.
14 secondary outcomes
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
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.
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.
Tumor biomarkers
Time frame: From pre-procedure to every follow-up time, assessed up to 2 years.
Tumor biomarkers
Time frame: From pre-procedure to every follow-up time, assessed up to 2 years.
Tumor biomarkers
Time frame: From pre-procedure to every follow-up time, assessed up to 2 years.
Eastern Cooperative Oncology Group Score
Time frame: 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,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: 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 15 Apr 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.
Linqiang Lai, MD. study director
The Central Hospital of Lishui City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting beads bronchial arterial chemoembolization, Serplulimab and Intravenous chemotherapy in people with Carcinoma and Small Cell Lung Cancer, run by The Central Hospital of Lishui City at 1 site 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 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Objective response rate (time frame: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria at 1 month, 3 months, and 6 months , assessed 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 15 Apr 2024.