EGFR mutant lung adenocarcinoma
Conditions
Interventions
Experimental group:After enrollment, patients will be treated with third-generation EGFR-TKIs in combination with chidamide, where the third-generation EGFR-TKIs will be
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Obtain signed informed consent from the patient; 2.Age 18 years or older and less than 75 years; 3.ECOG score of 0-1, with an expected survival of >= 3 months; 4.Ability to comply with the study protocol and follow-up procedures, and accept injectable drug therapy; 5.Target population includes patients with histologically or cytologically confirmed locally advanced or metastatic lung adenocarcinoma [American Joint Committee on Cancer (AJCC) 8th edition TNM stages IIIB, IIIC, or IV], assessed by the investigator as inoperable or unsuitable for surgical resection, and unsuitable for other radical treatments; 6.Previous treatment with third-generation EGFR-TKIs resulting in enlargement of the primary lesion or metastatic lesions, or disease progression; 7.At least one measurable target lesion according to RECIST 1.1 criteria; 8.Major organ function meeting the following criteria: (1) Blood routine: absolute neutrophil count = 1.5×10^9/L, platelets = 75×10^9/L, hemoglobin = 80 g/L (no use of any hematological components or cytokine growth factor correction therapy within 14 days prior to randomization); (2) Blood biochemistry: total bilirubin = 1.5 times the upper limit of normal, AST/ALT = 2.5 times the upper limit of normal (= 5 times the upper limit of normal if liver metastasis), serum creatinine <= 1.5 times the upper limit of normal; (3) Coagulation function: International Normalized Ratio (INR) < 1.5 (no anticoagulation therapy within 14 days prior to randomization, except for stable doses of prophylactic anticoagulation therapy). 9.Not participating in other clinical trials that may affect the results of this study.
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastases with neurological symptoms; Note: Patients with previous imaging evidence of brain metastases after local treatment for intracranial metastases (e.g., radiotherapy or surgery) were eligible if the metastatic lesions were stable and asymptomatic for at least 28 days. 2. Patients with major blood vessel invasion detected by imaging during the screening period or with high likelihood of major blood vessel invasion resulting in massive bleeding according to the investigator's judgment during the trial period; 3. Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage during the screening period; 4. Current or previous cancer (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence or metastasis within the last 5 years; 5. Use of radiotherapy, chemotherapy, or immunotherapy within 28 days before the first medication; 6. Major surgery (such as craniotomy, thoracotomy, or laparotomy) within 28 days before the first dose of medication or severe unhealed wounds, ulcers, or fractures at the time of screening; 7. There are obvious gastrointestinal abnormalities during the screening period, which may affect the intake, transport or absorption of drugs according to the investigator's judgment (such as inability to swallow, chronic diarrhea, intestinal obstruction, after small bowel resection, etc.), or total gastrectomy, or previous history of gastrointestinal perforation; 8. Active bleeding within 2 months before the first dose of medication, or taking anticoagulants during the screening period (e.g., warfarin, phenprocoumarin; prophylactic low-dose aspirin, low-molecular-weight heparin were allowed); Or the investigator judged that there was a high risk of bleeding (such as esophagogastric varices with a risk of bleeding, local active ulcer lesions, positive fecal occult blood could not rule out gastrointestinal bleeding, intermittent hemoptysis, etc.). 9. Screening test HIV antibody positive; 10. Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with viral replication, hepatitis C antibody (HCV-Ab) positive with viral replication. (Note: qualitative detection is preferred, and quantitative detection of viral replication is performed when necessary). 11. Have serious heart, liver, kidney diseases or other serious complications; 12. Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period; 13. Any mental or cognitive impairment that may limit their understanding and execution of informed consent and adherence to the study; 14. Patients judged by the investigator to be unable to participate in the study, such as patients with a high probability of not complying with the study charter, restrictions and requirements; Or other circumstances at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;AE;Disease control rate (DCR);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactSuwenmei
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed