NCT06090994 Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
| NCT ID | NCT06090994 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fudan University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 756 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 756 participants in total. It began in 2024-10-18 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multicenter, randomized, parallel controlled study to evaluate the effectiveness of Huaier Granule in preventing recurrence and metastasis after radical resection of colorectal cancer
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old, regardless of gender. * It is diagnosed as colorectal cancer by histopathology, TNM stage Ⅱ. * Received radical resection of colorectal cancer (R0) within 12 weeks prior to enrollment. * Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvant therapy after surgery. * ECOG score 0-2 points. * According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria for receiving monotherapy adjuvant therapy with capecitabine. * Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate in completing questionnaire assessments. * Voluntarily join this study and sign an informed consent form. Exclusion Criteria: * Low rectal cancer (occurring within 12 centimeters from the anal margin) * Combining medical history of other malignant tumors. * Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (only in the experimental group). * Inability to take orally medication (experimental group, control group with oral medication included in standard treatment plan). * Pregnant or lactating women or planned pregnancy preparation. * In the past one month, the subjects have received Huaier granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier granules (such as compound cantharides capsules, cinobufacin capsules, Kangai injection, Pingxiao tablets, please refer to the instruction manual for details). * Refusal to cooperate with follow-up. * Other reasons leading to the researcher's belief that it is not suitable to participate in this study.
Contact & Investigator
Sanjun Cai, PhD
📞 +8618121299134
Sanjun Cai, PhD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06090994 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06090994 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06090994 currently recruiting?
Yes, NCT06090994 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fudan University to inquire about joining.
Where is the NCT06090994 trial being conducted?
This trial is being conducted at Harbin, China, Changzhou, China, Nanjing, China, Yangzhou, China and 5 additional locations.
Who is sponsoring the NCT06090994 clinical trial?
NCT06090994 is sponsored by Fudan University. The principal investigator is Sanjun Cai, PhD at Fudan University. The trial plans to enroll 756 participants.
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