NSCLC
Conditions
Interventions
experimental group:Compound cantharidin capsule combined with EGFR-TKI
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1, Aged 18-80 years, gender is not limited; 2, Histological or cytological diagnosis of lung adenocarcinoma with EGFR mutation; 3. Patients with locally advanced or metastatic NSCLC with clinical stage IIIB or IV (root) According to UICC and AJCC, NSCLC TNM staging is 8th edition); 4. After treatment with EGFR-TKI, the effect is stable; 5. Have not received any palliative chemotherapy, if the patient has received neoadjuvant chemotherapy or assistance Chemotherapy, the end of chemotherapy time is >= 6 months from the time of enrollment in this study; 6. ECOG PS: 0-2 points; 7. The expected survival time is >= 3 months; 8. Patients who have received previous radiation therapy can be enrolled, subject to all of the following conditions: The main target lesion has not undergone radiotherapy or progress after radiotherapy; The acute toxicity of previous radiotherapy has been restored to = 4 weeks from the time of enrollment in this study; 9. There must be at least one measurable lesion (according to RECIST version 1.1); 10. Laboratory tests meet the following criteria: Bone marrow function: absolute count of blood neutrophils (ANC) >= lower limit of normal; blood small plate (PLT) >= 75×10^9/L; hemoglobin (HB) >= 90g/L; Liver function: serum total bilirubin (TBIL), direct bilirubin (DBIL) <= normal Upper limit (ULN) × 1.5; alanine aminotransferase (ALT), aspartate ammonia Base transferase (AST) <= ULN × 2.5 (in the absence of liver metastases); or <= ULN ×5 (when there is liver metastasis); Kidney function: creatinine (Cr) <= ULN; 11. The patient volunteers and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients known to be allergic to research drugs; 2, Combined with heart, liver, kidney and hematopoietic system and other serious diseases; received within 4 weeks before enrollment major surgery, or surgical wounds have not fully healed; 3. The toxic reaction caused by previous anti-tumor treatment is still >= CTC AE 2 grade; 4. Accept NMPA-approved immunologic preparations with anti-cancer indications within 1 week prior to enrollment or traditional Chinese medicine; 5. Participated in any clinical trial of research drugs within 4 weeks before enrollment; 6. Serious infection occurred within 1 week before the start of the study, requiring intravenous antibiotics and antifungals or antiviral therapy; 7. Suffering from serious mental illness, poor compliance; 8. Cases that the investigator considers inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactChen Gang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed