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

Primary Purpose

Colorectal Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huaier granule
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Huaier granule, colorectal cancer, Exploratory research, recurrence and metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harbin Medical University Cancer Hospital
  • The First People's Hospital of Changzhou
  • Jiangsu People's Hospital
  • Northern Jiangsu People's Hospital
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Sanjun Cai
  • Renji Hospital，Shanghai Jiao Tong University School of Medicine
  • Zhejiang Cancer Hospita
  • Ningbo Medical Center Lihuili Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Huaier Granule

Standard treatment

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
1-、2 -、3-year overall survival rate
The proportion of patients who survive within 1、2 and 3 years.
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.
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.
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.

Full Information

First Posted
October 15, 2023
Last Updated
October 15, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT06090994
Brief Title
Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Standard Treatment
Official Title
Exploratory Study on the Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier Granules With Standard Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Huaier granule, colorectal cancer, Exploratory research, recurrence and metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
648 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Huaier Granule
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Huaier granule
Other Intervention Name(s)
Z20000109（NMPA Approval Number）
Intervention Description
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.
Primary Outcome Measure Information:
Title
3-year disease-free survival rate (DFS)
Description
The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.
Time Frame
start of treatment until 3-year follow-up
Secondary Outcome Measure Information:
Title
1-year disease-free survival rate (DFS)
Description
The proportion of surviving patients who did not experience disease recurrence or metastasis within 1 years after R0 surgery.
Time Frame
start of treatment until 1-year follow-up
Title
2-year disease-free survival rate (DFS)
Description
The proportion of surviving patients who did not experience disease recurrence or metastasis within 2 years after R0 surgery.
Time Frame
start of treatment until 2-year follow-up
Title
1-、2 -、3-year overall survival rate
Description
The proportion of patients who survive within 1、2 and 3 years.
Time Frame
start of treatment until 3-year follow-up
Title
Quality of Life Score
Description
Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.
Time Frame
baseline period and start of treatment until 3-year follow-up
Title
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Description
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.
Time Frame
start of treatment until 3-year follow-up
Title
The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
Description
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.
Time Frame
start of treatment until 3-year follow-up
Other Pre-specified Outcome Measures:
Title
Changes in carcinoembryonic antigen (CEA) compared to baseline period (difference)
Description
The difference in carcinoembryonic antigen levels between the treatment and baseline periods.
Time Frame
start of treatment until 3-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjun Cai, PhD
Phone
+8618121299134
First Name & Middle Initial & Last Name or Official Title & Degree
Fangqi Liu, PhD
Phone
+8613917902221
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjun Cai, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binbin Cui, PhD
Phone
+8613351112888
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qicheng Lu, PhD
Phone
+8613915087018
Facility Name
Jiangsu People's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueming Sun, PhD
Phone
+8613505188397
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daorong Wang, PhD
Phone
+8618051062590
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren H Zhao, PhD
Phone
+8613918805942
Facility Name
Sanjun Cai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjun Cai
Phone
+8618121299134
Facility Name
Renji Hospital，Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Cui, PhD
Phone
+8613512177595
Facility Name
Zhejiang Cancer Hospita
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haixing Jv, PhD
Phone
+8613858184823
First Name & Middle Initial & Last Name & Degree
Qian Zhang, PhD
Phone
+8613588296045
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315046
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Cui, PhD
Phone
+8613506842539

12. IPD Sharing Statement

Plan to Share IPD
No

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

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