Summary
Celecoxib 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trials linking Celecoxib to Colorectal Cancer: 2 are currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00473980). The largest enrolment is 353 participants (NCT03026140). Registration activity spans 1998 to 2023. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2010 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
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 | 76.0 (trials 26.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 0 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 randomised controlled trial publications, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00473980 | Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients 1998 | completed | Phase 4 | 28 |
| NCT00064181 | Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer 2003 | completed | Phase 3 | 86 |
| NCT00043043 | Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia 2003 | completed | Phase 2 | — |
| NCT03926338 | Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer 2019 | recruiting | Phase 2 | 270 |
| NCT03026140 | Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer 2017 | recruiting | Phase 2 | 353 |
| NCT05933980 | Toripalimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer 2023 | status unknown | Phase 2 | 44 |
| NCT00001693 | Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 (SC-58635) in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients and Carriers 1998 | completed | Phase 1 | 20 |
| NCT00608595 | Celecoxib in Treating Patients With Early-Stage Rectal Cancer 2002 | terminated | Not applicable | 10 |
Published literature
- Clinical trial publication Protective effect of celecoxib against capecitabine induced hand and foot syndrome in patients with colorectal CancerKettana AM, Mostafa TM, Ghannam AA et al. · Cancer chemotherapy and pharmacology · 2025 · PMID 40622571
- Cochrane review Review of Network Meta-Analyses on the Efficacy of Chemopreventive Agents on Colorectal Adenomas and CancerRuan Y, Carbonell C, Brown K et al. · Cancer control : journal of the Moffitt Cancer Center · 2025 · PMID 40394866
- Systematic review Chemoprevention of Gastrointestinal Cancers: An Umbrella Review of Meta-Analyses of Randomized Controlled Trials and Cohort StudiesChan JE, Shanmugham S, Kumar S et al. · Clinical and translational science · 2025 · PMID 40344467
- Clinical trial publication Improved Survival With Adjuvant Cyclooxygenase 2 Inhibition in PIK3CA-Activated Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance)Nowak JA, Twombly T, Ma C et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · PMID 38889377
- Cochrane review Protective Effects of Long-Term Usage of Cyclo-Oxygenase-2 Inhibitors on Colorectal Cancer in Genetically Predisposed Individuals and Their Overall Effect on Prognosis: A Systematic ReviewNarayana SH, Mushtaq U, Shaman Ameen B et al. · Cureus · 2023 · PMID 37588311
- Meta-analysis Selective COX-2 inhibitors do not increase gastrointestinal reactions after colorectal cancer surgery: a systematic review and meta-analysisHu T, Liu CJ, Yin X et al. · BMC gastroenterology · 2023 · PMID 37580670
- Clinical trial publication Celecoxib as an adjuvant to chemotherapy for patients with metastatic colorectal cancer: A randomized controlled clinical studyMostafa TM, Alm El-Din MA, Rashdan AR · Saudi medical journal · 2022 · PMID 35022282
- Clinical trial publication Neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, in mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer (PICC): a single-centre, parallel-group, non-comparative, randomised, phase 2 trialHu H, Kang L, Zhang J et al. · The lancet. Gastroenterology & hepatology · 2022 · PMID 34688374
- Meta-analysis The efficacy of chemopreventive agents on the incidence of colorectal adenomas: A systematic review and network meta-analysisHeer E, Ruan Y, Mah B et al. · Preventive medicine · 2022 · PMID 35878711
- Clinical trial publication Phase II Trial of Adjuvant Dendritic Cell Vaccine in Combination with Celecoxib, Interferon-α, and Rintatolimod in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal MetastasesRamanathan R, Choudry H, Jones H et al. · Annals of surgical oncology · 2021 · PMID 33400000
- Meta-analysis Very-low-dose aspirin and surveillance colonoscopy is cost-effective in secondary prevention of colorectal cancer in individuals with advanced adenomas: network meta-analysis and cost-effectiveness analysisVeettil SK, Kew ST, Lim KG et al. · BMC gastroenterology · 2021 · PMID 33743605
- Randomized controlled trial Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205)Suwa Y, Watanabe J, Ota M et al. · Cancer chemotherapy and pharmacology · 2019 · PMID 30523381
- Cochrane review Effects of aspirin and non-aspirin nonsteroidal anti-inflammatory drugs on the incidence of recurrent colorectal adenomas: a systematic review with meta-analysis and trial sequential analysis of randomized clinical trialsVeettil SK, Lim KG, Ching SM et al. · BMC cancer · 2017 · PMID 29137605
- Randomized controlled trial Efficacy and safety of celecoxib monotherapy for mild to moderate depression in patients with colorectal cancer: A randomized double-blind, placebo controlled trialAlamdarsaravi M, Ghajar A, Noorbala AA et al. · Psychiatry research · 2017 · PMID 28528242
- Cochrane review Efficacy and safety profile of celecoxib for treating advanced cancers: a meta-analysis of 11 randomized clinical trialsChen J, Shen P, Zhang XC et al. · Clinical therapeutics · 2014 · PMID 25016505
- Cochrane review Chemoprevention of colorectal cancer: systematic review and economic evaluationCooper K, Squires H, Carroll C et al. · Health technology assessment (Winchester, England) · 2010 · PMID 20594533
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 Celecoxib approved for Colorectal Cancer?
Celecoxib 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 Celecoxib in clinical trials for Colorectal Cancer?
ClinicalTrials.gov lists 8 registered trials linking Celecoxib to Colorectal Cancer: 2 are currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00473980). The largest enrolment is 353 participants (NCT03026140). Registration activity spans 1998 to 2023.
What does the evidence show for Celecoxib in Colorectal Cancer?
Celecoxib has both completed registered trials and synthesis-level publications linked to Colorectal Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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.