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

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

Detailed Description
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this is an double blinded controlled preventive study to evaluate the preventive effect of this is an preventive traditional chinese medicine TDX105 plus Urea Ointment compared with placebo plus Urea Ointment on Regorafenib induced Dermatologic Toxicities

Official Title
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Randomized Controlled Clinical Trials to Evaluate the Preventive Effect of Traditional Chinese Medicine TDX105 on Anti-tumor Target Therapy Regorafenib Induced Dermatologic Toxicities

Conditions
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Hand and Foot Skin Reaction, Colorectal Cancer Stage IV

Intervention / Treatment
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* Drug: Traditional chinese medicine TDX105
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 6. Understand and agree to accept the treatment, and sign the informed consent. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional chinese medicine TDX105<br>Experimental group Traditional chinese medicine TDX105 (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) Basic care was the same in both groups, including routine care such as topical use of urea ointment | Drug: Traditional chinese medicine TDX105<br>* Experimental group Traditional chinese medicine TDX105<br>|
| Placebo Comparator: placebo<br>The control group received placebo granules mixed with dextrin and food coloring (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) - Basic care was the same in both groups, including routine care such as topical use of urea ointment | Drug: Placebo<br>* he control group received placebo granules mixed with dextrin and food coloring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of grade 3 hand-foot skin reaction | Evaluation criteria for common adverse events (CTCAE) 5.0 | Once a week from the beginning to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 1-2 hand and foot skin reaction rate | Evaluation criteria for common adverse events (CTCAE) 5.0 | Once a week from the beginning to 2 months | 
| Withdrawal rate of regorafenib within 2 cycles | Weekly telephone follow-up | Once a week from the beginning to 2 months | 
| progression-free survival | Response Evaluation Criteria In Solid Tumors 1.1 | Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months. | 
| tumor control rate | Response Evaluation Criteria In Solid Tumors 1.1 | Measures were taken every 2 months from date of randomization until the date of first documented progression, assessed up to 36 months. |