Immune checkpoint inhibitors have improved outcomes for patients with cancer, but immune checkpoint inhibitor-related skin rash is a common adverse event that may affect quality of life and continuation of anticancer therapy. This study aims to evaluate the efficacy and safety of Wucao Anfu Formula as an adjunctive treatment for immune checkpoint inhibitor-related rash. In this randomized controlled clinical study, eligible patients with grade 1-2 immune checkpoint inhibitor-related rash will be randomly assigned to receive standard topical corticosteroid treatment with or without Wucao Anfu Formula. The study will assess improvement of skin rash severity, symptoms, quality of life, and safety outcomes. The results may provide clinical evidence for integrative management of immune checkpoint inhibitor-related skin adverse events.
1. Patients aged 18 years or older. 2. Patients with malignant tumors treated with immune checkpoint inhibitors who developed immune checkpoint inhibitor-related rash.
1. Patients with severe uncontrolled systemic diseases or serious organ dysfunction.
Parallel
Wucao Anfu Formula
Other interventionWucao Anfu Formula is an external traditional Chinese medicine therapy. Participants in the intervention group will receive Wucao Anfu Formula external wet compress therapy in addition to standard management for immune checkpoint inhibitor-related rash. The intervention will be administered for 14 days according to the study protocol.
Standard management
Other interventionParticipants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
Rash Response Rate
The proportion of participants achieving complete response or partial response of immune checkpoint inhibitor-related rash after treatment according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria.
Change in Rash Severity Grade
Change in severity grade of immune checkpoint inhibitor-related rash assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria before and after treatment.
Treatment-related Adverse Events
Incidence and severity of adverse events during the study period.
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