Status:
UNKNOWN
Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Qianfoshan Hospital
Collaborating Sponsors:
Shandong Provincial Hospital
Conditions:
Advanced Non Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previ...
Detailed Description
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previ...
Eligibility Criteria
Inclusion
- Pathologically verified non-small-cell lung cancer;
- Clinical stage of IIIB/IIIC/IV (including postoperative recurrence) ;
- EGFR Exon 19del or Exon 21 L858R mutations;
- No previous anti-tumor therapy including chemotherapy, radiotherapy or local thermal ablation (except adjuvant radiotherapy after lung cancer surgery) ;
- ECOG PS 0-1;
- Anticipated survival time ≥3 months;
- At least one measurable lesions (according to RECIST 1.1, CT scan length ≥10mm, CT scan short diameter ≥15mm) except the ablation lesions (primary lesion or the largest recurrent lesion) ;
- Asymptomatic brain metastasis;
- The routine laboratory examination was normal (blood routine, liver and kidney function, blood coagulation function, etc The standard of blood routine examination should be met (No blood transfusion and blood products within 14 days) ; ANC≥1.5×109/L; PLT ≥80×109/L. B. Biochemical examination should meet the following criteria: TBIL≤ 1.5 ULN; ALT, Ast ≤ 2.5 ULN).
- Adequate tissue specimens for further analysis.
- Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during and within 1 month after the end of the study period; The serum or urine HCG test must be negative within 72 hours before admission to the study, and must be non-lactation period; (12)18-80 years old;
- (13)Patients signed informed consent;
Exclusion
- Mixed lung cancer including neuroendocrine or small-cell lung cancer;
- Multiprimary tumors during the past 5 years;
- Uncontrolled pleural or pericardial effusion;
- Patients with a history of interstitial lung disease disease or moderate to severe diffuse dysfunction of the lung;
- A severe infection (CTCAE \> 2) during the past 4 weeks, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization;
- baseline chest radiographic examination revealed active pulmonary inflammation.
- The patients experienced acute cardiac cerebrovascular disease such as acute cerebral infarction and acute coronary syndrome within 1 month, (8) The cardiovascular clinical symptoms or diseases were not well controlled, including the following cases: There is local active Ulcer Focus, and stool occult blood {(+ +) can not be included in the group } ; within 2 months, there are black stool, hematemesis history;
- Abnormal coagulation function with bleeding tendency;
- Congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (Hepatitis B reference: HBV DNA test above the normal limit; Hepatitis C reference: HCV virus or RNA test above the normal limit) ;
- Patients with a history of psychotropic substance abuse who are unable to quit or who have a mental disorder;
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04755738
Start Date
January 1 2022
End Date
March 31 2025
Last Update
September 5 2021
Active Locations (1)
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1
Xin Ye
Jinan, SD, China, +86250001