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

Phase 2

• Conditions: Hand and Foot Skin Reaction; Colorectal Cancer Stage IV
• Interventions: Drug: Traditional chinese medicine TDX105; Drug: Placebo

• Registration Number: NCT05289726
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-12-10
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-11
• Last Update Submitted: 2022-03-11
• Study First Posted: 2022-03-21
• Last Update Posted: 2022-03-21
• Study Start: 2022-04-18
• Primary Completion: 2022-07-18
• Study Completion: 2023-04-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

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

5. 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 Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional chinese medicine TDX105	Traditional chinese medicine TDX105	* 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
placebo	Placebo	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer hospital Chinese academy of Medical sciences; 🇨🇳 Beijing, Beijing, China