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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005671
Enrollment
Unknown
Registered
2022-03-01
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

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Interventions

Test group:Controlled group

Sponsors

Cancer hosptial Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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. 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

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.

Design outcomes

Primary

MeasureTime frame
Incidence of grade 3 hand and foot skin reaction;

Secondary

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

Countries

China

Contacts

Public ContactAIPING TIAN

Cancer hosptial Chinese Academy of Medical Sciences

aipingtian@126.com+86 18612002896

Outcome results

None listed

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