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Clinical study of Jiedu Sangen granules Inhibiting postoperative recurrence and metastasis of stage II~III colorectal cancer based on ‘combination of disease and syndrome’

Clinical study of Jiedu Sangen granules Inhibiting postoperative recurrence and metastasis of stage II~III colorectal cancer based on ‘combination of disease and syndrome’

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16008986
Enrollment
Unknown
Registered
2016-08-07
Start date
2016-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

Integrated traditional Chinese and Western medicine group:Standard western medicine treatment and Taking herbal granules
Western medicine group:Standard western medicine treatment

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University(Zhejiang Provincial Hospital of TCM)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Corresponding to diagnosis standards of diagnostic and treating standards of colorectal cancer(version 2010), postoperative patients of colorectal cancer of stage II with high risk factors, and stage III, according to AJCC or UICC colorectal cancers TNM staging system, diagnosed by pathology or cytology can participate in this study; 2. The sex of the patients is not restricted, aged 18 to 70 years old; 3. KPS score is more than 60; 4. Patients can start to receive adjuvant chemotherapy within 1.5 months after surgery; 5. Patients don not have major organ dysfunction, whose blood routine, hepatic and renal function, cardiac function are normal, hemoglobin is no less than 9 g/L, absolute neutrophil count (ANC) is no less than 1.5x10^9/L, platelet is no less than 100x109 /L, bilirubin is no more than 1.5 ULN, alkaline phosphatase (AP), aspartate turn ammonia enzyme (AST), and alanine aminotransferase (ALT) are no more than 2.5 times the upper limit of normal value (That ALT is no more than 5 ULN is allowed in the case of liver metastases). INR is no more than 1.5 ULN. APTT is no more than 1.2 ULN. Creatinine is no more than 1.5 ULN; 6. Patients can keep on taking treatment according to the doctors' advice with good compliance, and understand the situation of this study, also are willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients suffered from other tumor in the past 5 years; 2. Expected survival period of the patients is less than 3 months; 3. Patients have any acute or chronic disease, mental disorder, laboratory abnormalities, which may increase the risks involved in this study, or have an impact on the study results. Researchers make the judgement of the patients who are not suitable to participate in the study based on the analysis, including: (1) Patients have uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia in the past 12 months, in addition, ECG showed obvious ischemic changes; (2) Patients are in the active stage of bacteria or fungal or viral infection; (3) Patients have dementia or altered mental status so that they can not understand or express consent; 4. Pregnant, lactational patients; 5. Patients do not agree or can not accept chemotherapy; 6. The researchers think it is not appropriate for the patients who have poor compliance to participate in this study.

Design outcomes

Primary

MeasureTime frame
Disease-free survival;

Secondary

MeasureTime frame
Recurrence and metastasis rate of one year;

Countries

China

Contacts

Public ContactShen Minhe

Zhejiang Chinese Medical University

shenminhe@aliyun.com+86 13758186666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026