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

NCT ID: NCT06665334

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2028-12-31

Brief Summary

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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Huaier granule

Intervention Type: DRUG

Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Huaier granule

Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.

Intervention Type: DRUG

Other Intervention Names

Z20000109#NMPA Approval Number#

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ye Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ye Xu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Ye Xu, PhD

Role: CONTACT

xu_shirley021@163.com

+8613817171710

Other Identifiers

HE-202203

Identifier Type: -

Identifier Source: org_study_id