Clinical trial · Interventional
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
NCT05289726CI-TRIAL-00057234unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Stage IV | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Hand and Foot Skin Reaction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Traditional chinese medicine TDX105 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Traditional chinese medicine TDX105
- description
- * 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
- interventionNames
- Drug: Traditional chinese medicine TDX105
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- 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
- interventionNames
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYu S, Hu X, Tan Y, Wang C, Shao Z, Xiao Y, Liu H, Lv J, Li S, Jiang X, Zeng L, Tian A. Prophylactic effect of the traditional Chinese medicine formula danxiong granules (TDX105) on hand-foot skin reaction associated with the antitumor targeted drug regorafenib: a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Nov 6;16:1641477. doi: 10.3389/fphar.2025.1641477. eCollection 2025. PMID 41282614