NCT06665334Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 31 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- Oct 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT06665334
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 134
- From Oct 2024 to the primary completion date, Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received anti-tumor traditional Chinese patent medicines and simple preparations treatment within 1 month before enrollment (subject to the instructions)
- Currently participating in clinical trials of other drugs
Other illness
- Known to be allergic to the components of Huaier Granule, or to avoid or use Huaier Granule with caution (observation group)
- 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
Other
- Cannot take medicine orally
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.