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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06090994
Other study ID # HE-202209
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 2023
Est. completion date September 2028

Study information

Verified date October 2023
Source Fudan University
Contact Sanjun Cai, PhD
Phone +8618121299134
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 648
Est. completion date September 2028
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old, regardless of gender. - It is diagnosed as colorectal cancer by histopathology, TNM stage ?C or ?. - 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: ? those who are allergic to chemotherapy drugs and excipients; ? the patient has severe heart, liver, kidney and other dysfunction or serious cardiovascular disease; ? the patient is extremely thin, dehydrated, in poor nutritional status, or in a cachexia state; ? 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; ? Concomitant severe infection; ? 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 Design


Intervention

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.

Locations

Country Name City State
China The First People's Hospital of Changzhou Changzhou Jiangsu
China Zhejiang Cancer Hospita Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Jiangsu People's Hospital Nanjing Jiangsu
China Ningbo Medical Center Lihuili Hospital Ningbo Zhejiang
China Renji Hospital,Shanghai Jiao Tong University School of Medicine Shanghai Shanghai
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Sanjun Cai Shanghai Shanghai
China Northern Jiangsu People's Hospital Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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