Clinical trial · Interventional
Fuzheng Yiliu-1010
Based on the Real World Prospective Cohort Study, Two-way Analysis of the Dominant Population and Corresponding Phenotypic Characteristics of Patients With Colorectal Cancer Treated by Fuzheng Yiliu Therapy Combined With Adjuvant Chemotherapy
- 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)
Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by using real-world data and gene expression profile data.
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 Stage II and III | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fuzheng Yiliu Formulation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fuzheng Yiliu group
- interventionNames
- Drug: Fuzheng Yiliu Formulation
- type
- NO_INTERVENTION
- label
- control group
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The age of the patients was 18-75 years old; 2. Radical resection of colorectal cancer (negative margin) was performed; 3. Patients with stage II high risk and stage III colorectal cancer confirmed by histology; 4. No liver, peritoneal or distant metastasis was found; 5. Patients with colorectal cancer who received standard chemotherapy or radiotherapy after operation and had no recurrence or metastasis at the end of radiotherapy and chemotherapy; 6. ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above; 7. Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was less than 1.5 mg / dl; 8. Renal function: creatinine \< 1.8mg/dl. Exclusion Criteria: 1. Allergic to the drug of this scheme; 2. Pregnant or lactating women with fertility requirements during the study period; 3. Severe hypertension, coronary heart disease, diabetes and so on, which are under control for half a year due to cardiovascular accident and poor drug control, are accompanied with other uncontrollable benign diseases such as lung, kidney, liver, infection, etc; 4. Participate in other studies before and during treatment; 5. There was a history of other malignant tumors or multi-source tumors within one year; 6. Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or active phase; 7. Patients with tuberculosis or seizures who need to be treated (e.g. steroids or antiepileptic therapy).
References
Publications (0)
Data not yet available