Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Disease Attributes

All Drugs and Chemicals

Immunomodulating Agents

Adjuvants, Immunologic

Huaier granules should be taken continuously for at least 6 months until the end of the study, intolerable toxicity, withdrawal from the study for any reason, disease progression or death, whichever occurs first; Or the researcher determines that the subject no longer benefits. During the treatment period with Huaier Granules, the experimental group subjects are prohibited from using any other anti-tumor treatment regimen or other immune modulators (specific instructions shall prevail).

This includes the standard radiotherapy and chemotherapy regimen recommended by researchers in combination with the latest guidelines and clinical routines. The standard chemotherapy regimen includes Xelox regimen, mFOLFOX regimen, etc. Please refer to the drug manual for specific usage. The control group subjects are forbidden to use Huaier Granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier Granules or other immunomodulators (the specific instructions shall prevail).

Oral administration, 10g once, 3 times a day, starting within 1-2 months after surgery. Please refer to the medication manual for specific usage. Continuous use for at least 6 months.

Huaier granule

Sanjun Cai, PhD

Fangqi Liu, PhD

Binbin Cui, PhD

Qicheng Lu, PhD

Yueming Sun, PhD

Daorong Wang, PhD

Ren H Zhao, PhD

Sanjun Cai

Zhe Cui, PhD

Haixing Jv, PhD

Qian Zhang, PhD

Wei Cui, PhD

This study is a prospective, multicenter, and exploratory study aimed at evaluating the effectiveness of Huaier Granules in preventing postoperative recurrence and metastasis of colorectal cancer.

This study is expected to continuously include 648 colorectal cancer (CRC) patients diagnosed with stage IIC-III and undergoing radical resection (R0) who visited the selected research center from August 2023 to March 2025. Among them, 216 patients in the experimental group who were deemed unsuitable or refused postoperative adjuvant radiotherapy and chemotherapy after radical resection (R0) were included, and all patients received Huaier Granule treatment; The control group included 432 patients who received standard treatment after radical resection (R0). Patients in the experimental group began using Huaier granules within 1-2 months after surgery. The control group patients were treated with a standard radiotherapy and chemotherapy regimen recommended by researchers in combination with the latest guidelines and clinical routines. Patients are followed up every 3 months after enrollment until the end of the study, withdrawal from the study for any reason, or death, whichever occurs first.

Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Standard Treatment

Exploratory Study on the Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier Granules With Standard Treatment

The difference in carcinoembryonic antigen levels between the treatment and baseline periods.

The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.

The proportion of surviving patients who did not experience disease recurrence or metastasis within 1 years after R0 surgery.

The proportion of surviving patients who did not experience disease recurrence or metastasis within 2 years after R0 surgery.

The proportion of patients who survive within 1、2 and 3 years.

Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.

The definition and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of adverse events, and the incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population.

The definition and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of adverse events. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population.

Spots Global Cancer Trial Database for recurrence and metastasis