Trial reportThe oncologist2025
Efficacy and safety of regorafenib plus biweekly trifluridine/tipiracil for refractory metastatic colorectal cancer: a multicenter single-arm phase II trial.
Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Efficacy and safety of TAS-102 plus Surufatinib in third and later line metastatic pancreatic cancer: a prospective, single center and biomarker exploratory, phase II study.Molecular cancer · 2025Trial
- TAS-102 in combination with bevacizumab for second-line treatment of metastatic colorectal cancer with a hypertensive elderly patient: a case report.Frontiers in oncology · 2025Article
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
backgroundBoth regorafenib and trifluridine/tipiracil (TAS-102) monotherapies have shown significant but limited survival benefits in metastatic colorectal cancer (mCRC) cases who progress after standard treatments. This study aimed to evaluate the efficacy and safety of regorafenib plus biweekly TAS-102 in refractory mCRC.
methodsIn this single-arm multicenter phase II trial (ChiCTR2300071752), eligible patients received regorafenib at 120 mg/day for 21 days in a 4-week cycle or were treated with a dose-escalation strategy (80 mg/day, followed by weekly increase of 40 mg to 120 mg/day). TAS-102 was administered biweekly (30 mg/m2 bid on days 1-5). The primary endpoint was progression-free survival (PFS). The secondary endpoints included safety, response rate (ORR), disease control rate (DCR), and overall survival (OS).
resultsBetween March 1, 2022 and December 1, 2023, 28 patients were enrolled. Totally 24 patients had at least one response evaluation. Median PFS and OS were 4.9 months (95% CI, 4.2-5.6) and 15.4 months (95% CI, 11.1-19.7). The ORR was 8.3% and the DCR was 83.3%. Grade 3 or 4 treatment-related adverse events occurred in 21.4% of patients, including hypertension (7.1%), neutropenia (7.1%), thrombocytopenia (3.6%), and hoarseness (3.6%).
conclusionsRegorafenib plus biweekly TAS-102 showed promising benefits in refractory mCRC cases, and adverse events were generally tolerable and manageable. DISCUSSION: (ClinicalTrials.gov Identifier: ChiCTR2300071752. IRB Approved: KYLL-202203-026-1.).
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