Clinical trial · Interventional
Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
Evaluation and Mechanism of Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
NCT03716063CI-TRIAL-00035413unknownPhase 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)
This study will take disease-free survival time and recurrence and metastasis rate as the main evaluation indexes, to evaluate the clinical efficacy of strengthening the spleen and reducing phlegm method in patients with stage II high-risk and stage III 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Jianpi Huatan dispensing granule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- test group
- description
- The test group will oral Jianpi Huatan dispensing granule , once a day in the morning and evening, once a month for a course of treatment, a total of three courses.
- interventionNames
- Drug: Jianpi Huatan dispensing granule
- type
- PLACEBO_COMPARATOR
- label
- control group
- description
- The control group will oral drug:low-dose control granules (containing 1/10 of the dose of the experimental group) , once a day in the morning and evening, once a month for a course of treatment, a total of three courses
- interventionNames
- Drug: Jianpi Huatan dispensing granule
Primary outcomes (2)
- measure
- Disease-free survival time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria; 2. Radical resection of colorectal cancer was performed and adjuvant chemotherapy (based on 5-FU regimens for at least 3 months) was completed within 3 months of the end of chemotherapy; 3. Tumor Node Metastasis(TNM) stage is high-risk II stage and III stage; 4. Age 18-80 years, sex unlimited; 5. No recurrence or metastasis by imaging or doctor's clinical judgement; 6. Signed informed consent; Note \* According to National Comprehensive Cancer Network(NCCN )clinical guidelines: Phase II:T3-4N0M0; High-risk Phase II is defined as follows::a.T4;b. Less than 12 lymph nodes were detected;c. preoperative intestinal obstruction, perforation of tumor site;d. poor histological differentiation (except highly unstable microsatellite);e. neurological invasion and vascular tumor thrombus; f. positive or unknown margin, and insufficient margin safety distance. Phase III:T1-4N1-2M0. Exclusion criteria: 1. History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. Combined with severe heart, liver and kidney disease; 3. Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia; 4. The researchers determine that they were not suitable for the study.
References
Publications (1)
- DERIVEDLi L, Qu Q, Cui N, Cai L, Zou J, Wu J, Hao T, Wu Y. Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial. Front Pharmacol. 2022 Sep 13;13:944475. doi: 10.3389/fphar.2022.944475. eCollection 2022. PMID 36176445