Summary
Sorafenib 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 Sorafenib to Colorectal Cancer: 8 have completed. The most advanced is Phase 2 (NCT00865709). It plans or enrolled 198 participants. Registration activity spans 2005 to 2017. The literature layer holds 13 publications for this pair: 3 Cochrane reviews, 2 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2008 to 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 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 | 74.5 (trials 24.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other |
| Linked publications | 13 (5 clinical trial publications, 3 Cochrane reviews, 2 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 | ARID1A |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00865709 | Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects 2009 | completed | Phase 2 | 198 |
| NCT03251612 | Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer 2017 | completed | Phase 2 | 90 |
| NCT01471353 | Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer 2011 | completed | Phase 2 | 43 |
| NCT00703638 | Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors 2008 | completed | Phase 1 | 16 |
| NCT00134069 | Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer 2005 | completed | Phase 1 | 48 |
| NCT01183663 | Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) 2010 | completed | Phase 1 | 180 |
| NCT00979329 | Study on the Influence of Sunitinib and Sorafenib on Fatigue, QoL, Depression in Patients With Metastatic RCC or GIST 2008 | completed | Not applicable | 100 |
| NCT00989469 | Sorafenib With Irinotecan in Metastatic Colorectal Cancer (mCRC) and K-RAS Mutation 2009 | completed | PHASE1, PHASE2 | 64 |
Published literature
- Clinical trial publication Efficacy of hydrocolloid dressing for hand-foot skin reaction: J-SUPPORT 1701 APRON trialRyu A, Zenda S, Shimizu Y et al. · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026 · PMID 42337018
- Cochrane review Hand-foot skin reaction as a positive prognostic factor in vascular endothelial growth factor receptor-tyrosine kinase inhibitor treatmentHuang IH, Wu PC, Yeh CN et al. · British journal of pharmacology · 2026 · PMID 41967859
- Clinical trial publication Targeting SLC7A11 with sorafenib sensitizes stereotactic body radiotherapy in colorectal cancer liver metastasisHe J, Zhang Y, Luo S et al. · Drug resistance updates : reviews and commentaries in antimicrobial and anticancer chemotherapy · 2025 · PMID 40381225
- Clinical trial publication Activity of Sorafenib Plus Capecitabine in Previously Treated Metastatic Colorectal CancerGeorge TJ, Ivey AM, Ali A et al. · The oncologist · 2021 · PMID 33512054
- Clinical trial publication Sorafenib Plus Irinotecan Combination in Patients With RAS-mutated Metastatic Colorectal Cancer Refractory To Standard Combined Chemotherapies: A Multicenter, Randomized Phase 2 Trial (NEXIRI-2/PRODIGE 27)Samalin E, Fouchardière C, Thézenas S et al. · Clinical colorectal cancer · 2020 · PMID 32737004
- Cochrane review Health economic evaluation of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma: a systematic reviewWang H, Jin C, Fang L et al. · Cost effectiveness and resource allocation : C/E · 2020 · PMID 31938024
- Meta-analysis Targeted therapy for solid tumors and risk of hypertension: a meta-analysis of 68077 patients from 93 phase III studiesSantoni M, Conti A, Massari F et al. · Expert review of cardiovascular therapy · 2019 · PMID 31829045
- Clinical trial publication Monitoring metabolic response using FDG PET-CT during targeted therapy for metastatic colorectal cancerWoff E, Hendlisz A, Garcia C et al. · European journal of nuclear medicine and molecular imaging · 2016 · PMID 27072811
- Cochrane review Risk of treatment-related deaths with vascular endothelial growth factor receptor tyrosine kinase inhibitors: a meta-analysis of 41 randomized controlled trialsHong S, Fang W, Liang W et al. · OncoTargets and therapy · 2014 · PMID 25336977
- Meta-analysis Incidence and relative risk of hepatic toxicity in patients treated with anti-angiogenic tyrosine kinase inhibitors for malignancyIacovelli R, Palazzo A, Procopio G et al. · British journal of clinical pharmacology · 2014 · PMID 23981115
- Randomized controlled trial Sorafenib in combination with oxaliplatin, leucovorin, and fluorouracil (modified FOLFOX6) as first-line treatment of metastatic colorectal cancer: the RESPECT trialTabernero J, Garcia-Carbonero R, Cassidy J et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2013 · PMID 23532888
- Randomized controlled trial Role of cetuximab and sorafenib in treatment of metastatic colorectal cancerGalal KM, Khaled Z, Mourad AM · Indian journal of cancer · 2011 · PMID 21248446
- Systematic review Will targeted therapy hold its promise? An evidence-based reviewMurdoch D, Sager J · Current opinion in oncology · 2008 · PMID 18043264
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 ARID1A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sorafenib approved for Colorectal Cancer?
Sorafenib 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 Sorafenib in clinical trials for Colorectal Cancer?
ClinicalTrials.gov lists 8 registered trials linking Sorafenib to Colorectal Cancer: 8 have completed. The most advanced is Phase 2 (NCT00865709). It plans or enrolled 198 participants. Registration activity spans 2005 to 2017.
What does the evidence show for Sorafenib in Colorectal Cancer?
Sorafenib 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 ARID1A. 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.