Summary
Aflibercept 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lists 8 registered trials linking Aflibercept to Cancer: 1 is currently recruiting; 2 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04392479). The largest enrolment is 2000 participants (NCT03923036). Registration activity spans 2005 to 2023. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2021 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 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 | 67.0 (trials 17.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 2 completed, 5 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 randomised controlled trial publications, 1 systematic review) |
| Agent type | Biologic |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04392479 | TWICE-IRI: Optimization of Second-line Therapy With Aflibercept, Irinotecan (Day 1 or Day 1,3), 5-Fluorouracile and Folinic Acid in Patients With Metastatic Colorectal Cancer. A Randomized Phase III Study. 2020 | status unknown | Phase 3 | 202 |
| NCT00729157 | Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy 2008 | completed | Phase 2 | 41 |
| NCT01889680 | Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer 2014 | withdrawn | Phase 2 | — |
| NCT00601991 | A Multi-Center Phase 2 Study of VEGF Trap as a Single Agent in Acute Myeloid Leukemia 2007 | withdrawn | Phase 2 | — |
| NCT00896662 | Analysis of Dendritic Phenotype and Function of Patients Receiving VEGF-Trap on VGFT-ST-0202 2005 | completed | Not applicable | 9 |
| NCT06047379 | Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis 2023 | recruiting | PHASE1, PHASE2 | 134 |
| NCT03923036 | Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer 2019 | status unknown | Not applicable | 2,000 |
| NCT04252456 | Folfiri/aflIbercept in Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status 2018 | status unknown | Not applicable | 150 |
Published literature
- Clinical trial publication Aflibercept and 5-FU vs. FOLFOX as 1st line treatment for older adults or frail elderly patients with metastatic colorectal cancer - The randomized phase 2 AIO / IKF ELDERLY trial (AIO-KRK-0117 / IKF 629)Hofheinz RD, Weikersthal LFV, Dechow T et al. · European journal of cancer (Oxford, England : 1990) · 2026 · PMID 41905242
- Clinical trial publication Circulating hsa-miR-29c-3p and VEGF-A levels predict the response to FOLFIRI plus aflibercept in elderly metastatic colorectal cancer patientsToledano-Fonseca M, Cano-Osuna MT, Élez E et al. · European journal of clinical investigation · 2026 · PMID 40747746
- Cochrane review Impact of vascular endothelial growth factor inhibitor-induced hypertension on continued cancer treatment: a systematic review and meta-analysisNishizaki M, Shibutani Y · Hypertension research : official journal of the Japanese Society of Hypertension · 2026 · PMID 41501361
- Clinical trial publication A phase two trial evaluating FOLFIRI plus aflibercept after failure of FOLFOXIRI plus bevacizumab in patients with unresectable metastatic colorectal cancerAndo K, Satake H, Shimokawa M et al. · International journal of clinical oncology · 2025 · PMID 39891883
- Clinical trial publication Maintenance with 5-FU/LV-aflibercept after induction with FOLFIRI-aflibercept versus FOLFIRI-aflibercept until progression as second-line treatment in older adults with metastatic colorectal cancer: the AFEMA phase II randomized trialGarcía-Alfonso P, Elez E, Soto-Alsar J et al. · ESMO open · 2024 · PMID 39608305
- Clinical trial publication mFOLFOX6 versus mFOLFOX6 + aflibercept as neoadjuvant treatment in MRI-defined T3-rectal cancer: a randomized phase-II-trial of the German Rectal Cancer Study Group (CAO/ARO/AIO 0214)Hofheinz RD, Herrle F, Dechow T et al. · ESMO open · 2024 · PMID 39260162
- Cochrane review Narrative review of malignant ascites: epidemiology, pathophysiology, assessment, and treatmentIkegami T, Ishiki H, Kadono T et al. · Annals of palliative medicine · 2024 · PMID 38644553
- Randomized controlled trial A Phase II Study of FOLFIRI Plus Ziv-Aflibercept After Trifluridine/Tipiracil Plus Bevacizumab in Patients with Metastatic Colorectal Cancer: WJOG 11018GMatsumoto T, Yamamoto Y, Kotaka M et al. · Targeted oncology · 2024 · PMID 38427280
- Cochrane review Risk of antiangiogenic adverse events in metastatic colorectal cancer patients receiving aflibercept in combination with chemotherapy: A meta-analysisGe P, Han C, Reyila A et al. · Medicine · 2023 · PMID 37657052
- Cochrane review A systemic review and meta-analysis of Aflibercept plus FOLFIRI regimen as a second-line treatment for metastatic colorectal cancer: A PRISMA compliant pooled analysis of randomized controlled trials and single arm studies to assess efficacy and safetyThakur A, Chorawala MR, Patel RS · Critical reviews in oncology/hematology · 2023 · PMID 37257732
- Cochrane review Recent advances in the molecular targeted drugs for prostate cancerGao P, Li T, Zhang K et al. · International urology and nephrology · 2023 · PMID 36719528
- Randomized controlled trial Modeling Tumor Growth Using Partly Conditional Survival Models: A Case Study in Colorectal CancerFlynn JR, Curry M, Zhao B et al. · JCO clinical cancer informatics · 2023 · PMID 37713655
- Meta-analysis Efficacy and safety of aflibercept plus chemotherapy in metastatic colorectal cancer: A systematic review and PRISMA-Compliant single-arm Meta-Analysis of noncomparative clinical studies and randomized controlled trialsGe P, Reyila A, Li XY et al. · Journal of clinical pharmacy and therapeutics · 2022 · PMID 35229901
- Meta-analysis The best strategy for metastatic colorectal cancer (mCRC) patients in second-line treatment: A network meta-analysisXu Z, Peng X, Kong Y et al. · Cancer treatment and research communications · 2021 · PMID 34619647
- Systematic review Economic Evaluation of Monoclonal Antibodies in Metastatic Colorectal Cancer: A Systematic ReviewKoilakou S, Petrou P · Molecular diagnosis & therapy · 2021 · PMID 34816395
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 Aflibercept approved for Cancer?
Aflibercept 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 Aflibercept in clinical trials for Cancer?
ClinicalTrials.gov lists 8 registered trials linking Aflibercept to Cancer: 1 is currently recruiting; 2 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04392479). The largest enrolment is 2000 participants (NCT03923036). Registration activity spans 2005 to 2023.
What does the evidence show for Aflibercept in Cancer?
Aflibercept 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.