To hear about similar clinical trials, please enter your email below
Trial Title:
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
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Huaier Granule
Colorectal Cancer
CEA Level
Negative Conversion Rate
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Huaier granule
Description:
Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6
months.
Arm group label:
Huaier Granule
Other name:
Z20000109#NMPA Approval Number#
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06665334