Randomized Controlled Study of Preventive Effect of TDX105 on Regorafenib Induced Dermatologic Toxicities

Not Applicable

• Conditions: ????

• Registration Number: ITMCTR2200005671
• Lead Sponsor: Cancer hosptial Chinese Academy of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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. PS score = 3;
4. Aged = 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3 hand and foot skin reaction;

Secondary Outcome Measures

Name	Time	Method
progression-free survival;Rate of reduction, discontinuation, or discontinuation of regorafenib;Incidence of grade 1-2 hand and foot skin reaction;Disease control rate;