Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy

A Prospective, Multicenter, Randomized, Parallel Controlled Study Comparing Huaier Granules With Capecitabine Monotherapy for the Prevention of Recurrence and Metastasis After Radical Resection of Stage II Colorectal Cancer

This is a prospective, multicenter, randomized, parallel controlled study to evaluate the effectiveness of Huaier Granule in preventing recurrence and metastasis after radical resection of colorectal cancer

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Huaier granule; Drug: Capecitabine

Detailed Description

It is expected to include 756 patients with colorectal cancer (CRC) who were diagnosed as stage II and underwent radical resection (R0) according to the CSCO colorectal cancer guidelines 2022 and met the criteria for cabetabine monotherapy in the study center from July 2024 to June 2026. The experimental group was treated with Huaier Granule monotherapy, and 378 patients were expected to be included; The control group was treated with capecitabine monotherapy, and 378 cases were expected to be included. Patients in the experimental group began using Huaier granules within 14 days-2 months after surgery. Patients in control group received capecitabine treatment, with one course of treatment every 3 weeks, for a total of 4-6 courses. Patients will be visited every 12 weeks (± 14 days) for the first two years after enrollment, and every 24 weeks (± 14 days) for the third year, until the end of the study, withdrawal from the study for any reason, or death, whichever occurs first.

• Study Type: Interventional
• Enrollment (Estimated): 756
• 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
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Binbin Cui, PhD; Phone Number: +8613351112888
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Not yet recruiting
      • The First People's Hospital of Changzhou
      • Contact: Qicheng Lu, PhD; Phone Number: +8613915087018
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu People's Hospital
      • Contact: Yueming Sun, PhD; Phone Number: +8613505188397
    • Yangzhou, Jiangsu, China, 225001
      • Recruiting
      • Northern Jiangsu People's Hospital
      • Contact: Daorong Wang, PhD; Phone Number: +8618051062590
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
      • Contact: Ren H Zhao, PhD; Phone Number: +8613918805942
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Sanjun Cai
      • Contact: Sanjun Cai; Phone Number: +8618121299134
    • Shanghai, Shanghai, China, 200127
      • Not yet recruiting
      • Renji Hospital,Shanghai Jiao Tong University School of Medicine
      • Contact: Zhe Cui, PhD; Phone Number: +8613512177595
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Not yet recruiting
      • Zhejiang Cancer Hospita
      • Contact: Haixing Jv, PhD; Phone Number: +8613858184823
      • Contact: Qian Zhang, PhD; Phone Number: +8613588296045
    • Ningbo, Zhejiang, China, 315046
      • Not yet recruiting
      • 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 Ⅱ.
• Received radical resection of colorectal cancer (R0) within 12 weeks prior to enrollment.
• Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvant therapy after surgery.
• ECOG score 0-2 points.
• According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria for receiving monotherapy adjuvant therapy with capecitabine.
• Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate in completing questionnaire assessments.
• Voluntarily join this study and sign an informed consent form.

Exclusion Criteria:

• Low rectal cancer (occurring within 12 centimeters from the anal margin)
• Combining medical history of other malignant tumors.
• Known to be allergic to the components of Huaier 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, Kangai 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Huaier Granule; Oral administration of Huai'er granules, 10g once, 3 times a day, continued 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. It is recommended that Huai'er Granules be used for the first time within 14 days-2 months after surgery. Please refer to the drug instructions for specific usage.	Drug: Huaier granule; Oral administration, 10g once, 3 times a day, starting within 14 days-2 months after surgery. Please refer to the medication manual for specific usage.; Other Names: Z20000109（NMPA Approval Number）
Active Comparator: Capecitabine; Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d),day 1-14,with one course of treatment every 3 weeks，please refer to the drug instructions for specific usage.	Drug: Capecitabine; Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d),day 1-14,with one course of treatment every 3 weeks, for a total of 4-6 courses.

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
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
Overall survival (OS)	The time from randomization and enrollment on the day of the patient to death for any reason.	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
• Collaborators: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Sanjun Cai, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2029

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): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; capecitabine; Huaier granule; recurrence and metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Recurrence; Colorectal Neoplasms; Neoplasm Metastasis; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Capecitabine
• Other Study ID Numbers: HE-202401

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