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| Name | Class |
|---|---|
| Jiangxi Provincial Cancer Hospital | OTHER |
| Jiangxi Chest Hospital | UNKNOWN |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Zhejiang University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Treatment Group | Experimental | Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment. |
|
| Single Treatment Group | Active Comparator | Only receive drug-eluting beads bronchial arterial chemoembolization treatment. |
|
| 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 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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 |
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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 |
|---|---|---|
| Xihui Ying, MD. | The Central Hospital of Lishui City | Study Director |
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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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| OTHER |
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This study is an open-label study. The Participants and investigators are not blinded, but the outcomes assessor are blinded.
|
| Programmed Cell Death Protein 1 Inhibitor | Drug | 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. |
|
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. |
| 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, 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. |
| 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. | From pre-procedure to every follow-up time, 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 | 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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