Summary
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Colorectal Cancer: 1 is currently recruiting; 7 have completed. The most advanced is Phase 3 (NCT06950385). The largest enrolment is 263 participants (NCT02599324). Registration activity spans 2006 to 2025. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2010. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Colorectal Cancer ranks 1212 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Essentially zero; 5-year survival stage I: ~90% (resectable); stage IV: ~15% overall, ~20-30% with modern therapy and liver metastasis resection.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 48.5 (trials 26.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 7 completed, 0 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | APC |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT06950385 | Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis 2025 | recruiting | Phase 3 | 168 |
| NCT00337545 | Phase II Trial of RAD001 in Refractory Colorectal Cancer 2006 | completed | Phase 2 | 22 |
| NCT01387880 | Irinotecan, Cetuximab and Everolimus to Patients With Metastatic Colorectal Cancer 2010 | completed | Phase 2 | 100 |
| NCT00597506 | Expanded Cohort for Metastatic Colorectal Cancer (MCRC) Using Bevacizumab + Everolimus 2007 | completed | Phase 2 | 50 |
| NCT00375245 | Rapamycin With Grapefruit Juice for Advanced Malignancies 2006 | completed | Phase 1 | 41 |
| NCT01637194 | Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer 2008 | completed | Phase 1 | 12 |
| NCT00409994 | Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer 2006 | completed | PHASE1, PHASE2 | 44 |
| NCT02599324 | Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors 2015 | completed | PHASE1, PHASE2 | 263 |
Published literature
- Clinical trial publication A Phase 1 clinical study of temsirolimus (CCI-779) in Japanese patients with advanced solid tumorsFujisaka Y, Yamada Y, Yamamoto N et al. · Japanese journal of clinical oncology · 2010 · PMID 20430774
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target APC. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sirolimus approved for Colorectal Cancer?
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sirolimus in clinical trials for Colorectal Cancer?
ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Colorectal Cancer: 1 is currently recruiting; 7 have completed. The most advanced is Phase 3 (NCT06950385). The largest enrolment is 263 participants (NCT02599324). Registration activity spans 2006 to 2025.
What does the evidence show for Sirolimus in Colorectal Cancer?
Sirolimus has 7 completed trials and 1 linked publication for Colorectal Cancer. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target APC. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.