Trial reportThe oncologist2019
Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study.
Trial report in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01538680 (An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer), which is not on this map. Cited by 76 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Who cites it
76 citing papers in PubMed, 138 citations in OpenAlex.
- Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2.The oncologist · 2025Trial
- A phase IV study to evaluate the safety of fruquintinib in Chinese patients in real-world clinical practice.The oncologist · 2024Trial
- Efficacy and safety of fruquintinib dose-escalation strategy for elderly patients with refractory metastatic colorectal cancer: A single-arm, multicenter, phase II study.Cancer medicine · 2023Trial
- Phase II dose titration study of regorafenib in progressive unresectable metastatic colorectal cancer.Scientific reports · 2023Trial
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- Modulation of autophagy: a Phase II study of vorinostat plus hydroxychloroquine versus regorafenib in chemotherapy-refractory metastatic colorectal cancer (mCRC).British journal of cancer · 2022Trial
- Efficacy and safety of regorafenib dose-escalation therapy for Japanese patients with refractory metastatic colorectal cancer (RECC study).International journal of clinical oncology · 2022Trial
- Phase II study of lenvatinib for metastatic colorectal cancer refractory to standard chemotherapy: the LEMON study (NCCH1503).ESMO open · 2020Trial
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- Trial
- Article
- Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer.Life (Basel, Switzerland) · 2026Article
- CEA and CA-19-9 Dynamics Associate with Survival in Regorafenib-Treated Metastatic Colorectal Cancer: A Real-World Analysis.Journal of clinical medicine · 2026Article
- Article
- Screening of Novel Inhibitors Targeting the Non-ATP-binding Domain ofMedicinal chemistry (Shariqah (United Arab Emirates)) · 2026Article
- Regorafenib-Induced Stress Response Alters the Bioenergetic Profile of Osteosarcoma Cells and Modulates Gene Expression Associated with Metabolic regulation-a Potential Mechanism of Osteosarcoma Treatment-Related Adaptation.Cancer management and research · 2026Article
- Optimized Dosing of Regorafenib in Patients With Metastatic Colorectal Cancer: A Practical Guide for Oncologists, Advanced Practice Providers, and Pharmacists.Journal of the advanced practitioner in oncology · 2025Review
- Management of Elderly Colorectal Cancer Patients: A Comprehensive Review Encompassing Geriatric Assessment.Cancers · 2025Review
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- Real-World Study of Patients with Metastatic Colorectal Cancer and Long-Term Response to Regorafenib in the USA.Cancers · 2025Article
16 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 20 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the phase III CORRECT trial, regorafenib significantly improved survival in treatment-refractory metastatic colorectal cancer (mCRC). The CONSIGN study was designed to further characterize regorafenib safety and allow patients access to regorafenib before market authorization.
methodsThis prospective, single-arm study enrolled patients in 25 countries at 186 sites. Patients with treatment-refractory mCRC and an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1 received regorafenib 160 mg once daily for the first 3 weeks of each 4-week cycle. The primary endpoint was safety. Progression-free survival (PFS) per investigator assessment was the only efficacy evaluation.
resultsIn total, 2,872 patients were assigned to treatment and 2,864 were treated. Median age was 62 years, ECOG PS 0/1 was 47%/53%, and 74% had received at least three prior regimens for metastatic disease. Median treatment duration was three cycles. Treatment-emergent adverse events (TEAEs) led to dose reduction in 46% of patients. Regorafenib-related TEAEs led to treatment discontinuation in 9%. Grade 5 regorafenib-related TEAEs occurred in <1%. The most common grade ≥3 regorafenib-related TEAEs were hypertension (15%), hand-foot skin reaction (14%), fatigue (13%), diarrhea (5%), and hypophosphatemia (5%). Treatment-emergent grade 3-4 laboratory toxicities included alanine aminotransferase (6%), aspartate aminotransferase (7%), and bilirubin (13%). Ongoing monitoring identified one nonfatal case of regorafenib-related severe drug-induced liver injury per DILI Working Group criteria. Median PFS (95% confidence interval [CI]) was 2.7 months (2.6-2.7).
conclusionIn CONSIGN, the frequency and severity of TEAEs were consistent with the known safety profile of regorafenib. PFS was similar to reports of phase III trials. ClinicalTrials.gov: NCT01538680. IMPLICATIONS FOR PRACTICE: Patients with metastatic colorectal cancer (mCRC) who fail treatment with standard therapies, including chemotherapy and monoclonal antibodies targeting vascular endothelial growth factor or epidermal growth factor receptor, have few treatment options. The multikinase inhibitor regorafenib was shown to improve survival in patients with treatment-refractory mCRC in the phase III CORRECT (
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.