ArticleBMC cancer2025
Raltitrexed, S-1 and fruquintinib (RSF) in the treatment of refractory metastatic colorectal cancer: study protocol for a multicenter, prospective, single-arm, phase II trial.
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06427005 (Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies), which is not on this 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.
Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study
Who cites it
2 citing papers in PubMed.
- Sintilimab plus fruquintinib with or without radiotherapy for third-line treatment of colorectal cancer with liver metastases: study protocol for a randomized controlled, multicenter phase II trial.Frontiers in immunology · 2026Trial
- Second-line raltitrexed plus irinotecan (SALIRI) with bevacizumab, cetuximab, or alone for metastatic colorectal cancer: a prospective multicenter cohort-based secondary analysis of the SALLY trial.Journal of gastrointestinal oncology · 2026Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundMetastatic colorectal cancer (mCRC) remains a significant clinical challenge, particularly for patients who have failed standard first- and second-line therapies. Despite advancements in targeted therapies, options for third-line treatments are limited, with current regimens such as regorafenib, fruquintinib, and TAS-102 demonstrating modest efficacy. The RS regimen, combining raltitrexed and S-1, has shown improved objective response rates (ORR) and progression-free survival (PFS) compared to standard therapies. Fruquintinib, a vascular endothelial growth factor receptor (VEGFR) inhibitor, has also demonstrated efficacy in heavily pretreated mCRC patients, including those resistant to prior anti-VEGF therapies. Combining these agents in the RSF regimen leverages complementary mechanisms of action to address resistance and improve outcomes.
methodsThis multicenter, prospective, single-arm, open-label Phase II clinical trial evaluates the efficacy and safety of the RSF regimen in mCRC patients who have failed first- and second-line therapies. Eligible patients will receive S-1 orally (14 days), raltitrexed intravenously (day 1), and fruquintinib orally (14 days) in a 21-day cycle. The primary endpoint is ORR, assessed using RECIST v1.1 criteria. Secondary endpoints include PFS, overall survival (OS), disease control rate (DCR), and quality of life (QoL). Safety will be monitored per NCI-CTCAE v4.0 criteria. DISCUSSION: The RSF regimen represents a novel approach to third-line treatment in mCRC, integrating chemotherapy and targeted therapy to enhance tumor response while managing toxicity. By leveraging complementary mechanisms of action, this study aims to optimize therapeutic outcomes in heavily pretreated patients. Further clinical research is essential to validate efficacy, safety, and potential biomarkers for patient selection.
trial registrationClinicalTrials.gov identifier: NCT06427005, registered on 19 June 2024.
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