facial rash related to EGFR-TKIs
Conditions
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent, male and female aged at least 18 years old; 2. Patient with non-small cell lung cancer (NSCLC) diagnosed by histology or cytology, EGFR gene mutation positive; 3. Facial rash develops after the patient s taking EGFR-TKIs drugs; 4. Patient aware what condition with and understand the content of written informed consent form; 5. Life expectancy is greater than or equal to 3 months; 6. willing to abide by the agreement, use therapeutic agents according to doctor's advice, and accept regular follow-up with good compliance; 7. Complete the questionnaire by yourself or with assistance; 8. ECOG PS score 0-3 points; 9. All screening laboratory tests are performed according to the program requirements and need to be carried out within 14 days before the first dose; The values of the laboratory tests performed for screening must meet the following criteria: 1) Blood routine examination: (no blood transfusion within 14 days before screening, no use of G-CSF, no use of drugs to correct); hemoglobin (HB) >=90 g/L; absolute value of neutrophil count (ANC) >=1.5x10^9/L; platelet count (PLT) >=100x10^9/L; white blood cell count (WBC) >=4.0x10^9/L and =30g/L; Cr =60 mL/min (Cockcroft-Gault formula); APTT <=1.5 times ULN, while INR or PT <=1.5 times ULN (no anticoagulant therapy); 10. Women of childbearing age must have a serum pregnancy test within 3 days prior to the first dose and the results are negative. Male subjects of reproductive age women and partners who are women of childbearing age must agree to use effective methods of contraception during the study period and within 180 days of the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Facial rash was caused by non-EGFR-TKIs during screening period; 2. In 3 months, facial rash happened after radiotherapy, chemotherapy, targeted therapy and immunotherapy or patients had developed facial rash previously after chemotherapy, targeted therapy and immunotherapy; 3. In 1 year, a patient has a birth plan and women who are pregnant or lactating; 4. A patient has used drugs that may affect the test results within 4 or 14 days (with local antibiotics, topical steroids and other topical treatments within 14 days of Day 0 (baseline); use any systemic antibiotics within 7 days prior to Day 0); 5. A patient has uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina, arrhythmia or mental illness; 6. A patient has allergies and or allergic to related Chinese medicine; 7. A patient has mental illness, alcoholism, refrain from quitting, drug use or substance abuse; 8. At the discretion of the investigator, to exclude the history or current evidence of any disease, treatment, or laboratory abnormality that may confuse the study results, interfere with the patient's participation in the study procedure, or does not meet the best interests of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GAGS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skindex-16 scale scores;DLQL scores;itching Visual Analogue Scale/Score (VAS);pain Visual Analogue Scale/Score (VAS);targeted drug rash; | — |
Countries
China
Contacts
Public ContactLizhu Lin
The First Affiliated Hospital of Guangzhou University of TCM
Outcome results
None listed