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Not yet recruiting NCT06665334

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

Phase IV Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Huaier granule.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • Rate of CEA conversion to negative [Time frame: start of treatment until 2-year follow-up]
Secondary outcome measures (2)
  • 1 or 2-year disease-free survival rate (DFS) [Time frame: start of treatment until 2-year follow-up]
  • Quality of Life Score [Time frame: baseline period and start of treatment until 2-year follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06665334 · HE-202203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗