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NCT06090994
A Prospective, Multicenter, Randomized, Parallel Controlled Study Comparing Huaier Granules With Capecitabine Monotherapy for the Prevention of Recurrence and Metastasis After Radical Resection of Stage II Colorectal Cancer
Phase 4 trial testing Huaier granule in Colorectal Cancer in 756 participants. Currently enrolling.
1 July 2027
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 756 |
| Start date | 18 October 2024 |
| Primary completion | 1 July 2027 |
| Estimated completion | 1 November 2029 |
| Sites | 9 locations across China |
Drugs / interventions tested
- Huaier granule — full drug profile →
- Capecitabine (capecitabine) — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Fudan University
Who can join
18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
3-year disease-free survival rate (DFS)
Time frame: start of treatment until 3-year follow-up
The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06090994
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Huaier granule
Trials testing the same drug.
- NCT05498766 — Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients · Phase 4 · not yet recruiting
- NCT05839314 — Effect of Huaier Granule on the Treatment of Idiopathic Membranous Nephropathy · Phase 4 · recruiting
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
- NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06090994 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 6 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06090994.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing