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Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy

StatusRecruiting
PhasePhase 4
Started2024-10-18
View on ClinicalTrials.gov ↗

Amendment history

2025-05-06
Study Status v3
Re-verified, no change to tracked fields
2025-03-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-08→confirmed 2024-10-18
Study sitesdetails revised at 9 of 9 sites
2024-08-16
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Primary completion date2027-09→2027-07
Completion date2028-09→2029-11
Start date2023-10→2024-08
Enrollment target648→756
InterventionsHuaier granule (Drug)→Capecitabine (Drug), Huaier granule (Drug)
Eligibility criteria-645 characters
[...] diagnosed as colorectal cancer by histopathology, TNM stage ⅡC or ⅢⅡ. Previously underwentReceived radical resection of colorectal cancer with(R0) awithin postoperative12 evaluationweeks ofprior R0to enrollment. PriorNot toreceiving neoadjuvant therapy before surgery, the patient didand not receive other anti-tumor treatment and was judged by a doctor to be unsuitable for radiotherapy and chemotherapy (meetingreceiving any ofadjuvant the following criteria: ① those who are allergic to chemotherapy drugs and excipients; ② the patient has severe heart, liver, kidney and other dysfunction or seri [...] [...]
Secondary endpoints6 entries, revised
1-、2 -、3-year overallOverall survival rate(OS)
Study description-16 characters
This studyIt is expected to continuously include 648756 patients with colorectal cancer (CRC) patientswho were diagnosed withas stage IIC-IIIII and undergoingunderwent radical resection (R0) whoaccording visitedto the selectedCSCO researchcolorectal cancer guidelines 2022 and met the criteria for cabetabine monotherapy in the study center from AugustJuly 20232024 to MarchJune 20252026. Among them, 216 patients in theThe experimental group whowas weretreated deemed unsuitable or refused postoperative adjuvant radiotherapy and chemotherapy after radical resection (R0) were included, and all pati [...] [...]
Collaborators+45 characters
Huazhong University of Science and Technology
Study title-8 characters
Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With StandardCapecitabine TreatmentMonotherapy
2023-10-15
Original filing
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
Trial Details
NCT Number NCT06090994
Lead Sponsor Fudan University
Collaborators: Huazhong University of Science and Technology
Conditions Colorectal Cancer
Enrollment 756 participants
Start Date 2024-10-18
Primary Completion 2027-07 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2025-05-07