Clinical trial · Interventional
Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients
Synergistic Anti-tumor Effect of ChangTai Keli Based on Chemotherapy for Colon Cancer Patients：a Randomized, Parallel-group, Double-blind, Multicenter Clinical Study
NCT02510118CI-TRIAL-00018742unknownPhase 2 / Phase 3ClinicalTrials.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)
The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind, multicenter clinical study.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ChangTai Keli | Drug | — | UNRESOLVED |
| mFOLFOX6 | Drug | — | UNRESOLVED |
| Placebo ChangTai Keli | Drug | — | UNRESOLVED |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- conventional chemotherapy + placebo ChangTai Keli
- description
- Patients in this group will be given conventional chemotherapy medicine: modified FOLFOX6 (mFOLFOX6) chemotherapy or XELOX recommended by treatment guidelines for colon cancer, and the placebo ChangTai Keli corresponding to the traditional Chinese syndrome of dampness stasis type of spleen deficiency.
- interventionNames
- Drug: mFOLFOX6
- Drug: XELOX
- Drug: Placebo ChangTai Keli
- type
- EXPERIMENTAL
- label
- conventional chemotherapy + ChangTai Keli
- description
- Patients in this group will be given conventional chemotherapy medicine: modified FOLFOX6 (mFOLFOX6) chemotherapy or XELOX recommended by treatment guidelines for colon cancer, and the ChangTai Keli corresponding to the traditional Chinese syndrome of dampness stasis type of spleen deficiency, a herbal extract twice daily for 26 weeks for lower dosage.
- interventionNames
- Drug: mFOLFOX6
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. collaboration from hospital oncology patients in hospital. Confirmed by pathology or cytology for colon cancer, Ⅱ A - Ⅳ period of patients with colon cancer line (or late postoperative palliative chemotherapy). 2. age \> 18 years of age, and the 75 - year - old patient or less; 3. fitness score (ECOG PS) 2 minutes or less, expected lifetime \> 6 months; 4. volunteered for the clinical research, and sign the informed consent. Exclusion Criteria: 1. patients with other primary malignant tumors within 1 year; 2. intentional, severe liver and kidney disease patients with serious obstacle and function; 3. pregnancy or lactation women, mental disorders to cooperate to complete the healer; 4. is in other subjects or attended other drugs test interval \< 3 months. 5. do not meet the inclusion criteria;
References
Publications (0)
Data not yet available
No reference posted for this study.