NCT06665334

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Huaier granule	Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2028-12-01
• First posted: 2024-10-30
• Last updated: 2024-10-31