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DRUG CLASS:

Thymidine phosphorylase inhibitor

19d
TIBET: TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov)
P2, N=52, Completed, Borstkanker Onderzoek Groep | Active, not recruiting --> Completed | Trial completion date: Nov 2025 --> May 2026
Trial completion • Trial completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
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Lonsurf (trifluridine/tipiracil)
20d
Feasibility Study of Trifluridine/Tipiracil and Zolbetuximab as Third- or Later-Line Chemotherapy for CLDN18.2-Positive and HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma: A Study Protocol. (PubMed, Cancer Med)
Zolbetuximab is an anti-claudin18.2 (CLDN18.2) antibody, and the addition of zolbetuximab in combination with fluoropyrimidine and oxaliplatin as a first-line treatment for CLDN18.2-positive and HER2-negative gastric or gastroesophageal junction adenocarcinoma has been shown to improve survival. The secondary endpoints are the time to treatment failure, progression-free survival, overall survival, response rate, incidence of adverse events, and incidence of Grade 3 or higher adverse events. The results will be used to evaluate the feasibility of the treatment and are expected to be used to evaluate whether future trials can be conducted.
Clinical protocol • Journal
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HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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HER-2 negative • CLDN18.2 positive • CLDN18.2 positive + HER-2 negative
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oxaliplatin • Lonsurf (trifluridine/tipiracil) • Vyloy (zolbetuximab-clzb)
20d
Trifluridine/tipiracil enhances radiation-induced abscopal effects and augments PD-1 blockade in gastric cancer. (PubMed, Sci Rep)
PD-1 expression on CD8⁺ T cells increased after FTD/TPI + RT; adding anti-PD-1 further suppressed the second tumor growth. Our findings support clinical trials of this triple-combination strategy in advanced GC, particularly in subgroups refractory to immune checkpoint blockade.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
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Lonsurf (trifluridine/tipiracil)
22d
TriComB: Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients. (clinicaltrials.gov)
P1/2, N=48, Active, not recruiting, Gruppo Oncologico del Nord-Ovest | Trial completion date: Mar 2026 --> Nov 2026
Trial completion date
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Avastin (bevacizumab) • capecitabine • Lonsurf (trifluridine/tipiracil)
25d
Late-line Systemic Therapy in Metastatic Colorectal Cancer: A Narrative Review and Australian Expert Perspective. (PubMed, Clin Colorectal Cancer)
Agents such as trifluridine/tipiracil, regorafenib, and fruquintinib offer additional benefit in heavily pretreated mCRC. Anticipated paradigm shifts with novel agents may further refine management strategies and improve outcomes for these patients. As the landscape evolves, ongoing multidisciplinary collaboration will be essential in optimizing both patient selection and therapy sequencing as new options become available.
Review • Journal
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KRAS (KRAS proto-oncogene GTPase)
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Stivarga (regorafenib) • Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)
1m
FRUQUITAS trial: Study design of an ENGIC intergroup randomized phase III of trifluridine/tipiracil +/- fruquintinib in pre-treated metastatic gastro-oesophageal adenocarcinoma. (PubMed, Dig Liver Dis)
ENGIC 06 - PRODIGE 114 - FFCD 2401 - FRUQUITAS is designed to determine whether VEGFR inhibition with fruquintinib plus trifluridine/tipiracil can meaningfully improve survival outcomes in pre-treated mOGC.
P3 data • Journal
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FLT1 (Fms-related tyrosine kinase 1)
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Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)
1m
Trial initiation date
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CLDN18 (Claudin 18)
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Fruzaqla (fruquintinib) • Lonsurf (trifluridine/tipiracil)
1m
Predictive factors for early mortality after regorafenib or trifluridine/tipiracil initiation in metastatic colorectal cancer. (PubMed, Oncologist)
Our predictive model may help identify patients at high risk of early mortality after regorafenib or trifluridine/tipiracil initiation and support shared decision-making between clinicians and patients regarding further chemotherapy or best supportive care.
Retrospective data • Journal
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CRP (C-reactive protein)
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Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
1m
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer (clinicaltrials.gov)
P1, N=45, Recruiting, Roswell Park Cancer Institute | Trial completion date: Apr 2027 --> Apr 2029 | Trial primary completion date: Sep 2026 --> Sep 2028
Trial completion date • Trial primary completion date
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Talzenna (talazoparib) • Lonsurf (trifluridine/tipiracil)
1m
Enrollment open
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capecitabine • oxaliplatin • Lonsurf (trifluridine/tipiracil)
2ms
Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy (clinicaltrials.gov)
P1, N=15, Completed, University of California, Irvine | Active, not recruiting --> Completed
Trial completion
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RAS wild-type
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Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • Lonsurf (trifluridine/tipiracil)
2ms
Preclinical identification and clinical validation of dynamic biomarkers for trifluridine/tipiracil with or without bevacizumab in metastatic colorectal cancer. (PubMed, ESMO Gastrointest Oncol)
On-treatment changes in IL-8, AREG, and EREG may serve as prognostic-and potentially predictive-biomarkers of FTD/TPI efficacy in mCRC. These findings support further evaluation of biomarker-guided treatment strategies.
Preclinical • Journal
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CXCL8 (Chemokine (C-X-C motif) ligand 8) • EREG (Epiregulin) • IFI16 (Interferon Gamma Inducible Protein 16)
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Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil)