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

Colorectal Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05289726
• Other study ID #: APL21100510010105003002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 18, 2022
• Est. completion date: April 18, 2023

Study information

• Verified date: March 2022
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Aiping Tian, PhD
• Phone: 13651395732
• Email: aipingtian[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: April 18, 2023
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Stage IV
• Colorectal Neoplasms

Intervention

Drug:
• Traditional chinese medicine TDX105
Experimental group Traditional chinese medicine TDX105
• Placebo
he control group received placebo granules mixed with dextrin and food coloring

Locations

Country	Name	City	State
China	Cancer hospital Chinese academy of Medical sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Withdrawal rate of regorafenib within 2 cycles	Weekly telephone follow-up	Once a week from the beginning to 2 months
Secondary	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.
Secondary	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.