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

Phase 1

• Conditions: Rash caused by immune checkpoint inhibitors

• Registration Number: ITMCTR2200005924
• Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median time of disease remission;Drug efficiency;

Secondary Outcome Measures

Name	Time	Method
??????;Recurrence rate;Drug safety;Quality of life;