Last reviewed · How we verify
NCT05631041
The Possible Anticancer Effect of Silymarin in Patients With Metastatic Colorectal Cancer Receiving Chemotherapy.
Status unknown
Phase 3
Last updated 19 December 2023
What this trial tests
Phase 3 trial testing Silymarin in Metastatic Colorectal Cancer in 64 participants. Status unknown.
Timeline
31 December 2022
Primary endpoint
1 November 2024
1 November 2024
1 December 2024
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 31 December 2022 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Silymarin — full drug profile →
Conditions studied
- Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
Sponsor
Tanta University
Who can join
18 and older, any sex, with Metastatic 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.
-
The change between groups in response rate (RECIST)
Time frame: At baseline, pre-intervention and at the end of last chemotherapy cycle ( 3 months from the beginning ) patients will recieve either Folfiri 6 cycles ( each cycle is 14 days) or Xeliri 4 cycles ( each cycle is 21 days)
Tumor response is characterized by both objective response rates (ORR=Complete response + partial response) and disease control rate (DCR= complete response + partial response + stable disease). In addition, complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) will be evaluated. Follow-up for one year will be carried out to determine progression free sur
Sponsor's own description
this work is aim to assess the antitumor effect of silymarin in patients with metastatic colorectal cancer receiving chemotherapy with or without target therapy (Bevacizumab).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Oxidative Stress and Age-Related Tumors.
Di Carlo E, Sorrentino C. · · 2024 · cited 33× · PMID 39334768 · DOI 10.3390/antiox13091109 -
Silymarin and Silybin: Rejuvenating Traditional Remedies with Modern Delivery Strategies.
Li X, Zhu H, Wang Y, Zhang X, et al · · 2025 · PMID 41471139 · DOI 10.3390/pharmaceutics17121628 -
Mechanisms and advantages of natural derived small molecule compounds in the prevention and treatment of colorectal cancer: a review.
Liao MJ, Dong HY, Chen G, Li WW, et al · · 2025 · PMID 41001347 · DOI 10.3389/fphar.2025.1658493
Verify or expand the search:
- PubMed search for NCT05631041
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Silymarin
Trials testing the same drug.
- NCT06922669 — Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia · NA · recruiting
- NCT07123922 — Effect of Silymarin as Add on Therapy on Oxidative Stress, Pulmonary Function and Quality of Life in Stable COPD Patient · NA · enrolling by invitation
- NCT07001150 — Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease · Phase 2 · recruiting
- NCT06114719 — Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery · Phase 3 · completed
- NCT05595109 — Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients · Phase 2, PHASE3 · unknown
Other recruiting trials for Metastatic Colorectal Cancer
Currently open trials in the same condition.
- NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
- NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
- NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
- NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
- NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting
Other Tanta University trials
Trials by the same sponsor.
- NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients · NA · not yet recruiting
- NCT06966856 — This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcti · Phase 3 · not yet recruiting
- NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
- NCT07498998 — Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome · NA · not yet recruiting
- NCT07114250 — Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation · NA · 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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05631041 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tanta University
- Last refreshed: 19 December 2023
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/NCT05631041.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing