Clinical trial NCT06665334: To Explore the Effect of Huaier Granule on the Negative Conversion Rate After the CEA Level Increases Again After Colorectal Cancer Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: Huaier Granule
Colorectal Cancer
CEA Level
Negative Conversion Rate
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of CEA conversion to negative
timeFrame: start of treatment until 2-year follow-up
Secondary outcomes:
measure: 1 or 2-year disease-free survival rate (DFS)
timeFrame: start of treatment until 2-year follow-up
measure: Quality of Life Score
timeFrame: baseline period and start of treatment until 2-year follow-up
Other outcomes:
measure: The changes (rate values) of tumor markers (including but not limited to CA199, CA24-2, CA72-4, and CA50) compared to baseline
timeFrame: start of treatment until 2-year follow-up
Locations:
Study officials:
affiliation: Fudan University
name: Ye Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: