Clinical trial NCT06090994: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: Huaier granule
colorectal cancer
capecitabine
recurrence and metastasis
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
First posted: 2023-10-19
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: 3-year disease-free survival rate (DFS)
timeFrame: start of treatment until 3-year follow-up
Secondary outcomes:
measure: 1-year disease-free survival rate (DFS)
timeFrame: start of treatment until 1-year follow-up
measure: 2-year disease-free survival rate (DFS)
timeFrame: start of treatment until 2-year follow-up
measure: Overall survival (OS)
timeFrame: start of treatment until 3-year follow-up
measure: Quality of Life Score
timeFrame: baseline period and start of treatment until 3-year follow-up
measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE)
timeFrame: start of treatment until 3-year follow-up
measure: The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
timeFrame: start of treatment until 3-year follow-up
Other outcomes:
measure: Changes in carcinoembryonic antigen (CEA) compared to baseline period (difference)
timeFrame: start of treatment until 3-year follow-up
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Sanjun Cai
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital，Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospita
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Sanjun Cai, PhD
role: PRINCIPAL_INVESTIGATOR
References: