To Explore the Effect of Huaier Granule on the Negative Conversion Rate After the CEA Level Increases Again After Colorectal Cancer Surgery

Objective to Explore the Effect of Huaier Granule on the Negative Conversion Rate of Patients Whose Carcinoembryonic Antigen (CEA) Level Increases Again After Radical Resection of Colorectal Cancer

This study is a prospective, observational and exploratory study to explore the effect of Huaier Granule on the negative conversion rate of patients with increased CEA levels after colorectal cancer surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Huaier granule

Detailed Description

This study is a prospective, single center, observational study, expected to include patients who visited the selected research center from December 2022 to December 2024 and were pathologically diagnosed with stage I-III colorectal cancer and underwent R0 radical resection surgery. During routine clinical follow-up within one year after radical surgery, if serum CEA>5.2ng/ml occurs, patients may choose whether to use Huaier granules to prevent recurrence and metastasis according to their wishes. Patients who agree to use Huaier granules will enter the observation group; Patients who do not agree to use it will enter the control group. After the subjects are enrolled, they will be visited every 1 month ± 7 days in the first year, and every 3 months ± 14 days starting from the second year according to clinical routine diagnosis and treatment, until imaging examination determines disease progression, the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or the researcher determines no longer benefiting, whichever occurs first.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ye Xu, PhD; Phone Number: +8613817171710; Email: xu_shirley021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years old, gender not limited
• Diagnosed with colorectal cancer through histopathology, pTNM stage I-III
• Previously underwent radical resection for colorectal cancer, with a postoperative evaluation of R0
• Imaging did not detect recurrence or distant metastasis
• Serum CEA>5.2ng/ml within 1 year after surgery (found during routine clinical follow-up)
• Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation
• Voluntary participation in this study, good compliance, and signing of informed consent form.

Exclusion Criteria:

• Known to be allergic to the components of Huaier Granule, or to avoid or use Huaier Granule with caution (observation group)
• Cannot take medicine orally
• Have received anti-tumor traditional Chinese patent medicines and simple preparations treatment within 1 month before enrollment (subject to the instructions)
• Combining medical history of other malignant tumors
• Diabetes with serious heart, cerebrovascular and lung diseases, severe hypertension and poor blood sugar control
• Suffering from intestinal diverticulitis, rectal polyps, colitis, pancreatitis, cirrhosis, hepatitis, etc
• Currently participating in clinical trials of other drugs
• Pregnant or lactating women or those planning to conceive
• Refusing to cooperate with follow-up visits
• Other reasons led the investigators to believe that it was not suitable to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Huaier Granule; Oral administration of Huaier granule, 10g (1 bag) each time, 3 times a day, is recommended for at least 6 months until there is imaging progression of the disease, the end of the study, intolerable toxicity, withdrawal or death from the study for any reason, or the researcher determines that there is no longer benefit, whichever occurs first.	Drug: Huaier granule; Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.; Other Names: Z20000109#NMPA Approval Number#
No Intervention: Routine clinical treatment; During routine clinical follow-up, patients who underwent R0 resection were found to have abnormally elevated levels of CEA, and therefore no intervention was generally given. If there is imaging progress, intolerable toxicity, or withdrawal from the study for any reason during the research period (whichever occurs first), routine clinical treatment will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of CEA conversion to negative	The proportion of patients whose CEA levels returned to normal at each visit to the total number of patients at that follow-up.	start of treatment until 2-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 or 2-year disease-free survival rate (DFS)	The proportion of surviving patients who did not experience imaging recurrence, distant metastasis, or death within 1 or 2 years after enrollment.	start of treatment until 2-year follow-up
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 2-year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes (rate values) of tumor markers (including but not limited to CA199, CA24-2, CA72-4, and CA50) compared to baseline	The differences in tumor marker levels between treatment and baseline.	start of treatment until 2-year follow-up

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Ye Xu, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Huaier Granule; CEA Level; Negative Conversion Rate
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HE-202203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No