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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Huaier granule

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 648
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sanjun Cai, PhD; Phone Number: +8618121299134
• Study Contact Backup: Name: Fangqi Liu, PhD; Phone Number: +8613917902221

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
      • Contact: Binbin Cui, PhD; Phone Number: +8613351112888
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • The First People's Hospital of Changzhou
      • Contact: Qicheng Lu, PhD; Phone Number: +8613915087018
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu People's Hospital
      • Contact: Yueming Sun, PhD; Phone Number: +8613505188397
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
      • Contact: Daorong Wang, PhD; Phone Number: +8618051062590
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
      • Contact: Ren H Zhao, PhD; Phone Number: +8613918805942
    • Shanghai, Shanghai, China, 200032
      • Sanjun Cai
      • Contact: Sanjun Cai; Phone Number: +8618121299134
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital,Shanghai Jiao Tong University School of Medicine
      • Contact: Zhe Cui, PhD; Phone Number: +8613512177595
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Zhejiang Cancer Hospita
      • Contact: Haixing Jv, PhD; Phone Number: +8613858184823
      • Contact: Qian Zhang, PhD; Phone Number: +8613588296045
    • Ningbo, Zhejiang, China, 315046
      • Ningbo medical center lihuili hospital
      • Contact: Wei Cui, PhD; Phone Number: +8613506842539

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old, regardless of gender.
• It is diagnosed as colorectal cancer by histopathology, TNM stage ⅡC or Ⅲ.
• Previously underwent radical resection of colorectal cancer with a postoperative evaluation of R0.
• Prior to surgery, the patient did not receive other anti-tumor treatment and was judged by a doctor to be unsuitable for radiotherapy and chemotherapy (meeting any of the following criteria: ① those who are allergic to chemotherapy drugs and excipients; ② the patient has severe heart, liver, kidney and other dysfunction or serious cardiovascular disease; ③ the patient is extremely thin, dehydrated, in poor nutritional status, or in a cachexia state; ④ the patient's bone marrow hematopoietic function is inhibited, and white blood cells are less than 2×10^9/L or platelets < 50×10^9/L or severe anemia; ⑤ Concomitant severe infection; ⑥ Other contraindications to radiotherapy and chemotherapy determined by doctors or patients refusing to assist with radiotherapy and chemotherapy，patients in the control group plan to receive standard treatment after surgery.
• ECOG score 0-2 points.
• Agree to receive Huaier Granule treatment after enrollment (only in the experimental group).
• Conscious, capable of language expression or reading, able to communicate normally, and cooperate in completing questionnaire evaluations.
• Volunteer to join this study and sign an informed consent form.

Exclusion Criteria:

• History of merging with other malignant tumors.
• Known to be allergic to the components of Huai Er granules or avoid or use Huaier granules with caution (only in the experimental group).
• Inability to take orally medication (experimental group, control group with oral medication included in standard treatment plan).
• Pregnant or lactating women or planned pregnancy preparation.
• In the past one month, the subjects have received Huaier granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier granules (such as compound cantharides capsules, cinobufacin capsules, Kang'ai injection, Pingxiao tablets，please refer to the instruction manual for details.
• Refusal to cooperate with follow-up.
• Other reasons leading to the researcher's belief that it is not suitable to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Huaier Granule; 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).	Drug: Huaier granule; 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.; Other Names: Z20000109（NMPA Approval Number）
No Intervention: Standard treatment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease-free survival rate (DFS)	The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.	start of treatment until 3-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year disease-free survival rate (DFS)	The proportion of surviving patients who did not experience disease recurrence or metastasis within 1 years after R0 surgery.	start of treatment until 1-year follow-up
2-year disease-free survival rate (DFS)	The proportion of surviving patients who did not experience disease recurrence or metastasis within 2 years after R0 surgery.	start of treatment until 2-year follow-up
1-、2 -、3-year overall survival rate	The proportion of patients who survive within 1、2 and 3 years.	start of treatment until 3-year follow-up
Quality of Life Score	Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.	baseline period and start of treatment until 3-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)	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.	start of treatment until 3-year follow-up
The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)	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.	start of treatment until 3-year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in carcinoembryonic antigen (CEA) compared to baseline period (difference)	The difference in carcinoembryonic antigen levels between the treatment and baseline periods.	start of treatment until 3-year follow-up

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Sanjun Cai, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: colorectal cancer; Huaier granule; Exploratory research; recurrence and metastasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Recurrence
• Other Study ID Numbers: HE-202209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No