Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC
NCT ID: NCT06364046
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2024-04-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab
Drug-eluting beads bronchial arterial chemoembolization
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.
Serplulimab
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.
Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab
Serplulimab
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
Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days
Interventions
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Drug-eluting beads bronchial arterial chemoembolization
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.
Serplulimab
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
Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* Uncontrolled hypertension, diabetes, or cardiovascular disease;
* Allergy to contrast agents;
* Women who are pregnant or lactating.
18 Years
ALL
No
Sponsors
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The Central Hospital of Lishui City
OTHER
Responsible Party
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Principal Investigators
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Linqiang Lai, MD.
Role: STUDY_DIRECTOR
The Central Hospital of Lishui City
Locations
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Lishui central hospital
Lishui, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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ZJLS-KLDMIR-22006
Identifier Type: -
Identifier Source: org_study_id
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