Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Standard Treatment

• Sponsor: Fudan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06090994
• Collaborator: (none)
• Enrollment: 648
• Locations: 9
• Arms: 2
• Anticipated Duration (Months): 59
• Patients Per Site: 72
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Huaier granule	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 648 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exploratory Study on the Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier Granules With Standard Treatment
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2027
• Anticipated Study Completion Date: Sep 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Huaier Granule Huaier granules should be taken continuously for at least 6 months 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. During the treatment period with Huaier Granules, the experimental group subjects are prohibited from using any other anti-tumor treatment regimen or other immune modulators (specific instructions shall prevail).	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.; Other Names: Z20000109（NMPA Approval Number）
No Intervention: Standard treatment This includes the standard radiotherapy and chemotherapy regimen recommended by researchers in combination with the latest guidelines and clinical routines. The standard chemotherapy regimen includes Xelox regimen, mFOLFOX regimen, etc. Please refer to the drug manual for specific usage. The control group subjects are forbidden to use Huaier Granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier Granules or other immunomodulators (the specific instructions shall prevail).

Outcome Measures

Primary Outcome Measures

1. 3-year disease-free survival rate (DFS) [start of treatment until 3-year follow-up]

   The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.

Secondary Outcome Measures

1. 1-year disease-free survival rate (DFS) [start of treatment until 1-year follow-up]

   The proportion of surviving patients who did not experience disease recurrence or metastasis within 1 years after R0 surgery.

2. 2-year disease-free survival rate (DFS) [start of treatment until 2-year follow-up]

   The proportion of surviving patients who did not experience disease recurrence or metastasis within 2 years after R0 surgery.

3. 1-、2 -、3-year overall survival rate [start of treatment until 3-year follow-up]

   The proportion of patients who survive within 1、2 and 3 years.

4. Quality of Life Score [baseline period and start of treatment until 3-year follow-up]

   Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.

5. The incidence and severity of adverse events (AE) and severe adverse events (SAE) [start of treatment until 3-year follow-up]

   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.

6. The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) [start of treatment until 3-year follow-up]

   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.

Other Outcome Measures

1. Changes in carcinoembryonic antigen (CEA) compared to baseline period (difference) [start of treatment until 3-year follow-up]

   The difference in carcinoembryonic antigen levels between the treatment and baseline periods.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years old, regardless of gender.

• It is diagnosed as colorectal cancer by histopathology, TNM stage ⅡC or Ⅲ.

• 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: ① those who are allergic to chemotherapy drugs and excipients; ② the patient has severe heart, liver, kidney and other dysfunction or serious cardiovascular disease; ③ the patient is extremely thin, dehydrated, in poor nutritional status, or in a cachexia state; ④ 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; ⑤ Concomitant severe infection; ⑥ 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150081
2	The First People's Hospital of Changzhou	Changzhou	Jiangsu	China	213000
3	Jiangsu People's Hospital	Nanjing	Jiangsu	China	210029
4	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	China	225001
5	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200025
6	Sanjun Cai	Shanghai	Shanghai	China	200032
7	Renji Hospital，Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200127
8	Zhejiang Cancer Hospita	Hangzhou	Zhejiang	China	310005
9	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang	China	315046

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Sanjun Cai, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanjun Cai, professor, Fudan University
• ClinicalTrials.gov Identifier: NCT06090994
• Other Study ID Numbers: HE-202209
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sanjun Cai, professor, Fudan University: Huaier granule; colorectal cancer; Exploratory research; recurrence and metastasis
• Additional relevant MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis; Recurrence

Study Results

No Results Posted as of Oct 19, 2023