Colorectal Cancer
Conditions
Keywords
Huaier Granule, multisite, open-label, prospective
Brief summary
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
Detailed description
This is a multisite, open-label, prospective study investigating Huaier Granule for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery，to evaluate the efficacy and safety.
Interventions
None listed
Sponsors
Xi Shan Wang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females ages 18-75 years; 2. The first time to the therapy of patients who received the radical surgery within two months, Postoperative histopathology confirms the diagnosis of colorectal cancer with stage IIB, IIC and III ( TNM classification) 3. ECOG score of 0-2; 4. No history of malignant tumors; 5. The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.
Exclusion criteria
1. Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control; 2. confirmed infections after surgery ; 3. Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer; 4. Being infected with syphilis or with other blood-borne infectious diseases; 5. Pregnancy or lactation; or women of childbearing potential not using contraception; 6. Patients who have taken Traditional Chinese Medicines with efficacy and indications similar to that of Huaier granule - including, but not limited to, compound Banmao capsule., Huachansu capsule, Kangai Injection and Pingxiao tablets; 7. Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | 36 months | OS was defined as the time from participation to death from any cause or last patient last visit. |
| Local recurrence-Free Survival rate | 36 months | The proportion of Local recurrence-Free Survival subjects to the total number of subjects. |
| Distant Metastasis-Free Survival rate | 36 months | The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects. |
| Disease-Free Survival(DFS) | 36 months | Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quality of Life (QOL) | 36 months | Quality of Life (QOL) were measured using supplemental quality of life questions. Item score range（12 items）: 1 (worst symptom) to 5 (no symptom). Change: score at 36 months minus score at baseline. |
| Incidence rate of Adverse events (AE) | 36 months | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Severity of Adverse events | 36 months | An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Immunity function | 36 months | Immunity function was measured with Immune cells counts and positive rate. |
Countries
China
Contacts
Primary ContactXishan Wang, Professor
Outcome results
None listed