Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
1. Patients aged 18 years or older. 2. Patients with malignant tumors treated with immune checkpoint inhibitors 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 informed consent.
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 informed consent voluntarily.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Wucao Anfu Formula Group
Participants in this group will receive Wucao Anfu Formula external therapy in addition to standard management for immune checkpoint inhibitor-related rash.
|
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.
Andre navne:
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
|
|
Aktiv komparator: Control Group
Participants in this group will receive standard management for immune checkpoint inhibitor-related rash without Wucao Anfu Formula therapy.
|
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rash Response Rate
Tidsramme: 14 days after treatment initiation
|
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.
|
14 days after treatment initiation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Rash Severity Grade
Tidsramme: Baseline and 14 days after treatment initiation
|
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.
|
Baseline and 14 days after treatment initiation
|
|
Treatment-related Adverse Events
Tidsramme: Baseline to 14 days after treatment initiation
|
Incidence and severity of adverse events during the study period.
|
Baseline to 14 days after treatment initiation
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TYLL2026[Z]字 072
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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