Summary
Capecitabine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. ClinicalTrials.gov lists 8 registered trials linking Capecitabine to Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 1 has completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02854072). The largest enrolment is 300 participants (NCT02947061). Registration activity spans 2004 to 2026. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 3 systematic reviews and 5 clinical trial publications. The dated items are from 2026. 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 Cancer ranks 1226 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: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 69.5 (trials 19.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 2 active / not yet recruiting, 1 completed, 4 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 systematic reviews, 2 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02854072 | A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients 2015 | status unknown | Phase 3 | 148 |
| NCT01711242 | Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma 2012 | completed | Phase 2 | 208 |
| NCT07268677 | A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis. 2025 | not yet recruiting | Phase 2 | 30 |
| NCT07448077 | Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC 2026 | not yet recruiting | Phase 2 | 128 |
| NCT00459901 | Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer 2004 | terminated | Phase 2 | 13 |
| NCT02947061 | S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer 2015 | status unknown | Phase 2 | 300 |
| NCT06197581 | Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer 2024 | recruiting | Not applicable | 148 |
| NCT03167177 | QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy 2017 | withdrawn | PHASE1, PHASE2 | — |
Published literature
- Clinical trial publication Perioperative systemic therapy versus surgery alone for resectable colorectal peritoneal-only metastases (CAIRO6): a randomised, open-label, phase 3 trialRovers KP, Bakkers C, van den Heuvel TBM et al. · The Lancet. Oncology · 2026 · PMID 42372745
- Clinical trial publication Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trialMoolenaar LR, Ali M, Aufenacker TJ et al. · The lancet. Gastroenterology & hepatology · 2026 · PMID 42202843
- Clinical trial publication Dynamic thymidine kinase activity independently captures treatment-specific biological response and is independently associated with outcomes in endocrine-resistant HR+ /HER2 - metastatic breast cancer: A translational analysis of the GEICAM/2013-02 PEARL trialGuerrero-Zotano Á, Gil-Gil M, Williams A et al. · European journal of cancer (Oxford, England : 1990) · 2026 · PMID 42202479
- Clinical trial publication Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trialWu W, Yang Y, Chen H et al. · Signal transduction and targeted therapy · 2026 · PMID 42168151
- Clinical trial publication [(177)Lu]Lu-DOTATATE PRRT and CAPTEM chemotherapy for pancreas and small bowel neuroendocrine tumours: The AGITG CONTROL NETS Multi-centre randomized trialChan DL, Sjoquist KM, Ransom DT et al. · European journal of cancer (Oxford, England : 1990) · 2026 · PMID 42142431
- Cochrane review Prognostic significance of ctDNA mutations in advanced HER2-positive breast cancer treated with targeted therapy: A meta-analysisLin J, Xu H, Zhou Y et al. · Advances in clinical and experimental medicine : official organ Wroclaw Medical University · 2026 · PMID 42345502
- Cochrane review First-Line Chemotherapy Regimens for Unresectable Locally Advanced or Metastatic Biliary Tract Cancer: A Systematic Review and Bayesian Network Meta-AnalysisElemosho A, Blair AB, Angez M et al. · JAMA network open · 2026 · PMID 41984480
- Cochrane review Preventing Hand-Foot Syndrome in Patients With Cancer: A Systematic Review and Network Meta-AnalysisBaskarane H, Sahni S, Nagpal C et al. · JAMA dermatology · 2026 · PMID 41779386
- Cochrane review Individual Patient Data Meta-Analysis of Consensus Molecular Subtypes as Biomarkers of First-Line Treatment in RAS Wild-Type Metastatic Colorectal CancerStahler A, Modest DP, Stintzing S et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 · PMID 41252656
- Cochrane review Hand-foot syndrome prevention: pharmacological interventions-systematic review and network meta-analysisSaeteaw M, Thippharak T, Porasuntisuk K et al. · BMJ supportive & palliative care · 2026 · PMID 41207711
- Meta-analysis Integration Analysis of Bayesian and Machine Learning for Heterogeneity, Biomarkers, and Optimal Combination Regimens of Pucotenlimab in Solid TumorsHe Y, Gao C, Zhang S et al. · Cancer medicine · 2026 · PMID 42043855
- Meta-analysis Efficacy and safety of PRRT for the treatment of pancreatic neuroendocrine tumors: Systematic review and meta-analysisZhao J, Pei X, Li Y · Bulletin du cancer · 2026 · PMID 41387032
- Systematic review Evaluating adherence to literature-derived systemic therapy standards for resectable intrahepatic cholangiocarcinoma: A systematic review and cohort studyRussell B, Philips P, Scoggins CR et al. · European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology · 2026 · PMID 42127606
- Systematic review Tumor Lysis Syndrome in Colorectal Cancer-A Systematic Review of Literaturede Matos UMA, Tan WY, Forbes V · Journal of gastrointestinal cancer · 2026 · PMID 41893976
- Systematic review Systematic review of multimodal management strategies for Insulinoma-Induced hypoglycaemia: current evidence and future directionsZago E, Citone M, Canu L et al. · Endocrine · 2026 · PMID 41629460
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 Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Capecitabine approved for Cancer?
Capecitabine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Capecitabine in clinical trials for Cancer?
ClinicalTrials.gov lists 8 registered trials linking Capecitabine to Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 1 has completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02854072). The largest enrolment is 300 participants (NCT02947061). Registration activity spans 2004 to 2026.
What does the evidence show for Capecitabine in Cancer?
Capecitabine has both completed registered trials and synthesis-level publications linked to 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 Open Targets and ChEMBL. 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.