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

Xi Shan Wang

Status: Enrolling

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03349762

HE-201709

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,060 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,060 participants in 3 patient groups

Observational 1

Description:

Radiotherapy or Chemotherapy

Observational 2

Description:

Huaier Granule \& Radiotherapy or chemotherapy

Observational 3

Description:

Huaier Granules