Clinical trial · Interventional
To Explore the Effect of Huaier Granule on the Negative Conversion Rate After the CEA Level Increases Again After Colorectal Cancer Surgery
Objective to Explore the Effect of Huaier Granule on the Negative Conversion Rate of Patients Whose Carcinoembryonic Antigen (CEA) Level Increases Again After Radical Resection of Colorectal Cancer
NCT06665334CI-TRIAL-00082106not yet recruitingPhase 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 study is a prospective, observational and exploratory study to explore the effect of Huaier Granule on the negative conversion rate of patients with increased CEA levels after colorectal cancer surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Huaier granule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Huaier Granule
- description
- Oral administration of Huaier granule, 10g (1 bag) each time, 3 times a day, is recommended for at least 6 months until there is imaging progression of the disease, the end of the study, intolerable toxicity, withdrawal or death from the study for any reason, or the researcher determines that there is no longer benefit, whichever occurs first.
- interventionNames
- Drug: Huaier granule
- type
- NO_INTERVENTION
- label
- Routine clinical treatment
- description
- During routine clinical follow-up, patients who underwent R0 resection were found to have abnormally elevated levels of CEA, and therefore no intervention was generally given. If there is imaging progress, intolerable toxicity, or withdrawal from the study for any reason during the research period (whichever occurs first), routine clinical treatment will be administered.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old, gender not limited * Diagnosed with colorectal cancer through histopathology, pTNM stage I-III * Previously underwent radical resection for colorectal cancer, with a postoperative evaluation of R0 * Imaging did not detect recurrence or distant metastasis * Serum CEA\>5.2ng/ml within 1 year after surgery (found during routine clinical follow-up) * Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation * Voluntary participation in this study, good compliance, and signing of informed consent form. Exclusion Criteria: * Known to be allergic to the components of Huaier Granule, or to avoid or use Huaier Granule with caution (observation group) * Cannot take medicine orally * Have received anti-tumor traditional Chinese patent medicines and simple preparations treatment within 1 month before enrollment (subject to the instructions) * Combining medical history of other malignant tumors * Diabetes with serious heart, cerebrovascular and lung diseases, severe hypertension and poor blood sugar control * Suffering from intestinal diverticulitis, rectal polyps, colitis, pancreatitis, cirrhosis, hepatitis, etc * Currently participating in clinical trials of other drugs * Pregnant or lactating women or those planning to conceive * Refusing to cooperate with follow-up visits * Other reasons led the investigators to believe that it was not suitable to participate in this study
References
Publications (0)
Data not yet available
No reference posted for this study.