Randomized controlled clinical study on the efficacy and safety of Qingxue granule in improving immune-related cutaneous adverse events of advanced malignant tumor

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078130

Enrollment

Unknown

Registered

2023-11-29

Start date

2023-12-01

Completion date

Unknown

Last updated

2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune-related cutaneous adverse events of advanced malignant tumor

Interventions

treatment group :Qingxue granule

Control group :placebo granule

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age:18-80 years old.Gender is not limited; (2) Patients with advanced malignant tumors confirmed by pathology or cytology; (3) Patients with maculopapular rash or rash while on immune checkpoint inhibitors,with or without pruritus,will be included,regardless of whether they have other immune-related adverse events; (4) Expected survival time= 3 months; (5) The score of KPS =60; (6) Patients who have good compliance and sign the informed consent voluntarily; (7) Patients who agree not to participate in other interventional clinical trials during the treatment period.

Exclusion criteria

Exclusion criteria: (1) Patients with grade 3 or higher ircAEs; (2) Patients diagnosed with bullous pemphigoid/Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), psoriasiform eruptions, and capillary endothelial proliferation; (3) Patients with other serious organic diseases or severe abnormalities in liver and renal function; (4) Patients who have previous skin disease history or a family history of skin disease; (5) Patients known or suspected to be allergic to the known components in Qingxue granule; (6) Patients with a history of long-term use of hormone drugs and /or immunosuppressants; (7) Patients suffering from severe malabsorption or other diseases affecting absorption in the gastrointestinal tract; (8) Patients with mental illness who are unable to cooperate with the clinical trial; (9) Other conditions that are judged to be unsuitable for participation in the trial by the researcher.

Design outcomes

Primary

Measure	Time frame
Classification variation of immune-related cutaneous adverse events.;	—

Secondary

Measure	Time frame
Remission time of ircAEs;Variation of Maculopapular rash/rash area as a percentage of Body Surface Area.;Percentage of salvage therapy;Dermatology Life Quality Index, DLQI;the Karnofsky performance status;Proportion of immunotherapy interruptions during the trial.;	—

Countries

China

Contacts

Public ContactXu Yun

Xiyuan Hospital,China Academy of Chinese Medical Science

xyxiao78@163.com+86 152 1077 5378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026