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The goal of this clinical trial is to explore the safety and efficacy of cryoablation combined with carlizumab and apatinib in multiple primary lung cancer without known driver genes.Main included population criteria:Clinical and pathological diagnosis of multiple primary lung cancer;Three pulmonary nodules were diagnosed initially or before surgery, without lymph node metastasis;Male or female is 18 years old, and 75 years old;Up to one surgical resection treatment with 2 remaining pulmonary nodules, and postoperative pathology confirmed MIA or AIS and so on.The main questions it aims to answer is safety of cryoablation combined with carilizumab and apatinib in multiple primary lung cancer.Participants will take carplus with apatinib started 2-3 weeks after cryoablation. Carelizumab 200mg, q3w, apatinib 250mg, qd. Every 3 weeks is for one treatment cycle. Until PD, intolerable toxicity, death, patient withdrawal or investigator discretion requires termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patients were started on Carrelizumab in combination with Apatinib 2-3 weeks after cryoablation. Karelizumab 200 mg, q3w, and Apatinib 250 mg, qd. Every 3 weeks is a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Karelizumab+Apatinib | Drug | Karelizumab 200mg, q3w, and Apatinib 250mg, qd. every 3 weeks as a treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| irAEs rate | Incidence of adverse events occurring during treatment | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Proportion of patients whose tumor volume shrinks to a pre-specified value and who can maintain the minimum timeframe requirement, as the sum of the proportion in complete and partial remission | 3 years |
| DCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengzhi Zhou, doctor | Contact | 13560351186 | doctorzcz@163.com | |
| Xiaohong Xie, master | Contact | 13632326736 | gyxxh@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Chengzhi Zhou, doctor | The First Affiliated Hospital of Guangzhou Medical University,Guangzhou | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengzhi Zhou | Recruiting | Guangzhou | Guangdong | 510145 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Number of cases in remission (PR+CR) and stable lesions (SD) after treatment as a percentage of evaluable cases
| 3 years |
| DOR | the time between the first time a subject in confirmed complete remission (CR) or confirmed partial remission (PR) reaches confirmed complete remission (CR) or confirmed partial remission (PR) and the time of the first disease progression or death of any cause | 3 years |
| PFS | Time from start of patient's treatment to disease progression or death from any cause | 3 years |
| OS | Time from patient randomization to patient death from any cause | 3 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |