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

Official title

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

Overview

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

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 3-year disease-free survival rate (DFS) [Time frame: start of treatment until 3-year follow-up]

Secondary outcome measures (6)

• 1-year disease-free survival rate (DFS) [Time frame: start of treatment until 1-year follow-up]
• 2-year disease-free survival rate (DFS) [Time frame: start of treatment until 2-year follow-up]
• Overall survival (OS) [Time frame: start of treatment until 3-year follow-up]
• Quality of Life Score [Time frame: baseline period and start of treatment until 3-year follow-up]
• The incidence and severity of adverse events (AE) and severe adverse events (SAE) [Time frame: 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) [Time frame: start of treatment until 3-year follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 9 centers

• Harbin Medical University Cancer Hospital — Harbin
• The First People's Hospital of Changzhou — Changzhou
• Jiangsu People's Hospital — Nanjing
• Northern Jiangsu People's Hospital — Yangzhou
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
• Sanjun Cai — Shanghai
• Renji Hospital，Shanghai Jiao Tong University School of Medicine — Shanghai
• Zhejiang Cancer Hospita — Hangzhou
• … and 1 more center

Identifiers

NCT: NCT06090994 · HE-202401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗