acneiform rash
Conditions
Interventions
experimental group:Preventive treatment of acne like rash with 0.1% tacrolimus ointment start from the first day of receiving cetuximab treatment
control group :When rash occurs after cetuximab treatment, standard regimen treatment is given
Sponsors
Huadong hospital affilicated to Fudan university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years, TNM: stage IV, confirmed as RAS/BRAF V600E wild-type left side colorectal adenocarcinoma by histological and genetic molecular testing, and receiving first-line treatment with cetuximab combined with FOLFOX or FOLFIRI regimen; 2. ECOG score:0-2; 3. The expected survival period is greater than 3 months; 4. According to RECIST 1.1 standard, patients have evaluable or measurable target lesions; 5. The main organ function meets the following criteria within 7 days before treatment (no blood transfusion within 14 days before screening): blood white blood cell count >= 3.0 × 109/L, absolute neutrophil count >= 1.5 × 109/L, hemoglobin concentration >= 80g/L, platelet count >= 100 × 109/L, serum total bilirubin = 60mL/min; 6. The subjects voluntarily enrolled, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Individuals who are allergic to any experimental drug; 2. There are contraindications for the treatment of 0.1% tacrolimus ointment or hydrocortisone butyrate ointment; 3. Acne like rash has been treated with other medications (such as corticosteroids, antibiotics, etc.); 4. The presence of other rashes at the same time makes it difficult to accurately grade and evaluate acne like rashes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of CTCAE = 2 grade acne like rash; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;Disease remission rate of tumors;Progression-Free Survival;Safety of 0.1% tacrolimus ointment; | — |
Countries
China
Contacts
Public ContactJingwen Wang
Huadong hospital affilicated to Fudan university
Outcome results
None listed