UnknownPhase 2

Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105

China152 participantsStarted 2022-04-18

Plain-language summary

this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Clinically confirmed colorectal cancer patients;
✓. It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;
✓. Performance Status score ≤3;
✓. Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms

✕. Patients with skin reactions affected by simultaneous use of other targeted drugs (sorafenib, sunitinib, fruquintinib, etc.), chemotherapy drugs (capecitabine, doxorubicin, etc.) or hand-foot radiotherapy;
✕. Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
✕. Patients in the study who cannot cooperate with the continuation of this treatment;
✕. Sudden changes in the patient's condition affected and interfered with the researcher

incidence of grade 3 hand-foot skin reaction

Timeframe: Once a week from the beginning to 2 months

NCT IDNCT05289726

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-18

Aiping Tian, PhD