Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery

Detailed Description
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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.

Official Title
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A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females ages 18-75 years; 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) ECOG score of 0-2; No history of malignant tumors; The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data. Exclusion Criteria: Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control; confirmed infections after surgery ; Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer; Being infected with syphilis or with other blood-borne infectious diseases; Pregnancy or lactation; or women of childbearing potential not using contraception; 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; Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational 1<br>Radiotherapy or Chemotherapy | |
| Observational 2<br>Huaier Granule & Radiotherapy or chemotherapy | |
| Observational 3<br>Huaier Granules | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Free Survival(DFS) | Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death. | 36 months | 
| Overall survival(OS) | OS was defined as the time from participation to death from any cause or last patient last visit. | 36 months | 
| Local recurrence-Free Survival rate | The proportion of Local recurrence-Free Survival subjects to the total number of subjects. | 36 months | 
| Distant Metastasis-Free Survival rate | The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Quality of Life (QOL) | 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. | 36 months | 
| Incidence rate of Adverse events (AE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | 36 months | 
| Severity of Adverse events | 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. | 36 months | 
| Immunity function | Immunity function was measured with Immune cells counts and positive rate. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huaier Granule, multisite, open-label, prospective