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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer Stage IV; Hand and Foot Skin Reaction
• Intervention / Treatment: Drug: Traditional chinese medicine TDX105; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Aiping Tian, PhD; Phone Number: 13651395732; Email: aipingtian@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Libo Yao; Phone Number: 010-87788446; Email: hejie@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Traditional chinese medicine TDX105; Experimental group Traditional chinese medicine TDX105
Placebo Comparator: 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	Drug: Placebo; he control group received placebo granules mixed with dextrin and food coloring

What is the study measuring?

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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): April 18, 2022
• Primary Completion (Anticipated): July 18, 2022
• Study Completion (Anticipated): April 18, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: APL21100510010105003002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Do not participate in data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No