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

NCT06090994 | Recruiting Phase 4 DMC

• 1 other identifier: HE-202401
• Study Type: interventional
• Target: 756
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

Huaier granule; colorectal cancer; capecitabine; recurrence and metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 1-year disease-free survival rate (DFS)

  start of treatment until 1-year follow-up

• 2-year disease-free survival rate (DFS)

  start of treatment until 2-year follow-up

• Overall survival (OS)

  start of treatment until 3-year follow-up

• Quality of Life Score

  baseline period and start of treatment until 3-year follow-up

• The incidence and severity of adverse events (AE) and severe adverse events (SAE)

  start of treatment until 3-year follow-up

Other Outcomes (1)

• Changes in carcinoembryonic antigen (CEA) compared to baseline period (difference)

  start of treatment until 3-year follow-up

Study Arms (2)

Huaier Granule

EXPERIMENTAL

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

Capecitabine

ACTIVE COMPARATOR

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

Interventions

Huaier granule DRUG

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.

Also known as: Z20000109（NMPA Approval Number）

Huaier Granule

Capecitabine DRUG

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.

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Huazhong University of Science and Technology: collaborator

Study Sites (9)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213000, China

NOT YET RECRUITING

Jiangsu People's Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Sanjun Cai

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Renji Hospital，Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

NOT YET RECRUITING

Zhejiang Cancer Hospita

Hangzhou, Zhejiang, 310005, China

NOT YET RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315046, China

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sanjun Cai, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjun Cai, PhD

CONTACT

+8618121299134

Fangqi Liu, PhD

CONTACT

+8613917902221

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 19, 2023
• Study Start: October 18, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)