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

• Status: Not yet recruiting
• Trial end date: 2023-04-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Criteria

Inclusion Criteria:

1. Clinically confirmed colorectal cancer patients;

2. It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;

3. Performance Status score ≤3;

4. Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms

6. Understand and agree to accept the treatment, and sign the informed consent.

Exclusion Criteria:

1. 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;

2. Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;

3. Patients in the study who cannot cooperate with the continuation of this treatment;

4. Sudden changes in the patient's condition affected and interfered with the researcher