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

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT03349762
• Lead Sponsor: Xi Shan Wang

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-22
• Study Start: 2018-11-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3060

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (22)

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First Clinical Hospital affiliated to Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Hubei Cancer Hospita; 🇨🇳 Wuhan, Hubei, China

Union Hospital Tongji College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China

Changzhou No.2 People's Hospital; 🇨🇳 Changzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Northern Jiangsu People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China

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