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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab | Experimental |
| |
| Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-eluting beads bronchial arterial chemoembolization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Evaluation index of clinical efficacy of anticancer drugs. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | The most common primary endpoint in cancer trials. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfei Tu, DR. | Contact | +8613646782878 | jianfei1133@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Linqiang Lai, MD. | The Central Hospital of Lishui City | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lishui central hospital | Lishui | Zhejiang | 323000 | China |
Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
Within six months after the trial is completed.
Shared data is not available for downloading, but can only be browsed. To download the data, you must contact the researchers.
Shared data does not provide any private information of the participants.
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
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| Serplulimab | Drug | 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 chemotherapy | Procedure | Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days |
|
The best efficacy endpoint in cancer clinical trials.
| 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. | 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 | 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. | 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 | From pre-procedure to every follow-up time, assessed up to 2 years. |
| Tumor biomarkers | squamous cell carcinoma | From pre-procedure to every follow-up time, assessed up to 2 years. |
| Tumor biomarkers | carbohydrate antigen 125 | From pre-procedure to every follow-up time, assessed up to 2 years. |
| Tumor biomarkers | carcinoembryonic antigen | 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. | 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 | 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. | 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 | 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 | From date of randomization to every follow-up time, assessed up to 2 years. |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |