An interventional study of Wucao Anfu Formula and Standard management in Immune Checkpoint Inhibitor-related Rash and Immune-related Adverse Events, sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
mmune checkpoint inhibitors (ICIs) have become important treatments for various malignant tumors. However, immune-related adverse events, especially skin toxicities such as rash and dermatitis, occur frequently during ICI therapy and may negatively affect patients' quality of life and anticancer treatment adherence. Current management strategies mainly include skin care, antihistamines, and topical corticosteroids. Evidence regarding the role of traditional Chinese medicine-based external therapy as an adjunctive intervention remains limited.
This study is a multicenter, randomized, parallel-controlled clinical trial designed to evaluate the efficacy and safety of Wucao Anfu Formula as an adjunctive treatment for ICI-related rash. A total of 72 eligible participants with grade 1-2 ICI-related inflammatory skin rash will be randomly assigned in a 1:1 ratio to the intervention group or control group.
Both groups will receive standardized skin care and topical corticosteroid treatment. Participants in the intervention group will additionally receive Wucao Anfu Formula external wet compress therapy twice daily for 14 days. The control group will receive standard topical corticosteroid treatment alone.
The primary outcome is the overall improvement rate of ICI-related rash at day 14 after treatment. Secondary outcomes include changes in rash severity according to Common Terminology Criteria for Adverse Events (CTCAE), rash-related clinical symptoms and signs, itching severity, skin dryness, dermatology-specific quality of life, performance status, rescue treatment use, and safety outcomes including adverse events and laboratory examinations.
The study will provide clinical evidence regarding whether Wucao Anfu Formula can improve ICI-related rash while maintaining safety, and may contribute to the development of integrative approaches for managing immune-related adverse events during cancer immunotherapy.
68 studies on the registry are indexed under Exanthema; 11 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 45 interventional studies indexed under Exanthema.
Browse Exanthema studies →First Teaching Hospital of Tianjin University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 11 are open to participants now.
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1. Patients aged 18 years or older. 2. Patients with malignant tumors treated with who developed immune checkpoint inhibitor-related rash.
3. Patients meeting the diagnostic criteria for immune checkpoint inhibitor-related rash.
4. Patients voluntarily participating in the study and providing written .
Exclusion Criteria:
1. Patients with severe uncontrolled systemic diseases or serious organ dysfunction.
2. Patients with other skin diseases that may affect evaluation of rash. 3. Patients allergic to any component of Wucao Anfu Formula. 4. Pregnant or breastfeeding women. 5. Patients unable to complete the treatment protocol or follow-up. 6. Patients who withdraw voluntarily.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive Wucao Anfu Formula external therapy in addition to standard management for immune checkpoint inhibitor-related rash.
Other: Wucao Anfu Formula · Other: Standard management
Participants in this group will receive standard management for immune checkpoint inhibitor-related rash without Wucao Anfu Formula therapy.
Other: Standard management
Wucao 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.
Also known as: 五草安肤方
Participants 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.
Time frame: 14 days after treatment initiation
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.
Time frame: Baseline and 14 days after treatment initiation
Treatment-related Adverse Events
Incidence and severity of adverse events during the study period.
Time frame: Baseline to 14 days after treatment initiation
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine