Clinical trial · Interventional
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
A Prospective, Multicenter, Randomized, Parallel Controlled Study Comparing Huaier Granules With Capecitabine Monotherapy for the Prevention of Recurrence and Metastasis After Radical Resection of Stage II Colorectal Cancer
NCT06090994CI-TRIAL-00089395recruitingPhase 4ClinicalTrials.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 a prospective, multicenter, randomized, parallel controlled study to evaluate the effectiveness of Huaier Granule in preventing recurrence and metastasis after radical resection of colorectal cancer
Conditions
Conditions (1)
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Huaier granule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Huaier Granule
- description
- Oral administration of Huai'er granules, 10g once, 3 times a day, continued until the end of the study, intolerable toxicity, withdrawal from the study for any reason, disease progression or death, whichever occurs first; Or the researcher determines that the subject no longer benefits. It is recommended that Huai'er Granules be used for the first time within 14 days-2 months after surgery. Please refer to the drug instructions for specific usage.
- interventionNames
- Drug: Huaier granule
- type
- ACTIVE_COMPARATOR
- label
- Capecitabine
- description
- Oral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d),day 1-14,with one course of treatment every 3 weeks,please refer to the drug instructions for specific usage.
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old, regardless of gender. * It is diagnosed as colorectal cancer by histopathology, TNM stage Ⅱ. * Received radical resection of colorectal cancer (R0) within 12 weeks prior to enrollment. * Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvant therapy after surgery. * ECOG score 0-2 points. * According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria for receiving monotherapy adjuvant therapy with capecitabine. * Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate in completing questionnaire assessments. * Voluntarily join this study and sign an informed consent form. Exclusion Criteria: * Low rectal cancer (occurring within 12 centimeters from the anal margin) * Combining medical history of other malignant tumors. * Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (only in the experimental group). * Inability to take orally medication (experimental group, control group with oral medication included in standard treatment plan). * Pregnant or lactating women or planned pregnancy preparation. * In the past one month, the subjects have received Huaier granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier granules (such as compound cantharides capsules, cinobufacin capsules, Kangai injection, Pingxiao tablets, please refer to the instruction manual for details). * Refusal to cooperate with follow-up. * Other reasons leading to the researcher's belief that it is not suitable to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.