ITMCTR2200005924Not yet recruitingPhase 1
Clinical study on the efficacy and safety of Pi-Yan-Ning in the treatment of grade II-III maculopapular rash caused by immune checkpoint inhibitors
The First Affiliated Hospital of Zhejiang Chinese Medical University0 sitesStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •(1) =18 years old, males or females;
- •(2) Receive ICIs treatment;
- •(3) Confirmed by the joint consultation of oncologists and dermatologists or skin biopsy, diagnosed with grade II-III maculopapular rash according to the guideline of the management of immune checkpoint inhibitor-related toxicity formulated by CSCO;
- •(4) The general condition is good, KPS>60, and the estimated survival time= 3 months;
- •(5) The functional level of main organs should meet the following standards: ? Routine blood test: ANC=1.5×10^9/L; PLT=80×10^9/L; Hb=90g/L; ? Biochemical test: TBIL<1.5×ULN; ALT, AST<2.5×ULN (liver metastasis<5×ULN), BUN and Cr=1×ULN or Ccr=50ml/min (Cockcroft Gault formula);
- •(6) Adhere to medication according to the doctor's advice, cooperate with follow-up, understand the situation of this study and sign informed consent.
Exclusion Criteria
- •(1) The estimated survival time<3 months;
- •(2) There are adverse reactions of other systems caused by ICIs, such as immune hepatitis, pneumonia, encephalitis, myocarditis, etc;
- •(3) Exist the skin lesions or diseases affecting the study, or have a history of drug contact allergy;
- •(4) Received corticosteroid or any other drugs that may affect ICIs-related maculopapular rash within 1 week before the start of the study, including proprietary Chinese medicine and herbal medicine;
- •(5) Serious or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases);
- •(6) Any unstable systemic disease (including active infection, grade 3 hypertension, unstable angina pectoris, congestive heart failure, liver, kidney or metabolic diseases);
- •(7) Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- •(8) Pregnant or lactating patients;
- •(9) The subject may not be able to complete the study or comply with the requirements of the study (due to management or other reasons).
Investigators
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