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

Phase 4

Not yet recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: Huaier granule

• Registration Number: NCT06665334
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-10
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Huaier Granule	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1 or 2-year disease-free survival rate (DFS)	start of treatment until 2-year follow-up	The proportion of surviving patients who did not experience imaging recurrence, distant metastasis, or death within 1 or 2 years after enrollment.
Quality of Life Score	baseline period and start of treatment until 2-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.