A Phase 4 interventional study of Huaier granule in Colorectal Cancer, sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Fudan University · Phase 4, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 134 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.
Also known as: Z20000109#NMPA Approval Number#
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.
Time frame: start of treatment until 2-year follow-up
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.
Time frame: 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.
Time frame: baseline period and start of treatment until 2-year follow-up
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.
Time frame: start of treatment until 2-year follow-up
No study locations are listed for this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fudan University