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Trifluridine-tipiracil plus Bevacizumab Alone

Phase 2

Refractory Metastatic Colorectal Cancer | Small molecule | Oncology |Delcath Systems, Inc.|Last Updated: Jun 1, 2026

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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical trial landscape

Trifluridine-tipiracil plus Bevacizumab Alone · 1 trial · 1 indication

Phase 2 1
NCT06607458Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant DiseaseRefractory Metastatic Colorectal Cancer
RECRUITING90 Analytics
PHASE2RECRUITING
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease
Refractory Metastatic Colorectal CancerUnlock trial analytics
Study Endpoints
Primary Endpoints
hPFS
time from randomization to the first occurrence of hepatic disease progression, assessed over 24 months

Hepatic Progression Free Survival

Secondary Endpoints
PFS
time from randomization to the first occurrence of progression, assessed up to 24 months
OS
time from randomization date to the date of death due to any cause, assessed up to 36 months
ORR
Baseline through completion of treatment, assessed up to 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Melphalan/HDS followed by Consolidation Treatment with Trifluridine-tipiracil plus BevacizumabEXPERIMENTALMelphalan/HDS is given as an infusion of Melphalan into the hepatic artery under general anesthesia. This treatment is administered twice, 8 weeks apart. Following 2 treatments with Melphalan/HDS, Trifluridine-tipiracil is given 35 mg/m2 up to a maximum of 80 mg per dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle; and intravenous (IV) bevacizumab 5 mg/kg body weight on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity
Trifluridine-tipiracil plus Bevacizumab AloneACTIVE_COMPARATORTrifluridine-tipiracil plus Bevacizumab is the standard of care for patients with metastatic colorectal cancer. Trifluridine-tipiracil is given 35 mg/m2 up to a maximum of 80 mg per dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle; and intravenous (IV) bevacizumab 5 mg/kg body weight on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity
Interventions
NameTypeDescription
Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus BevacizumabDRUGTrifluridine-tipiracil plus Bevacizumab Alone
Trifluridine-tipiracil plus Bevacizumab AloneDRUGTrifluridine-tipiracil plus Bevacizumab Alone
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Histologically confirmed diagnosis of metastatic colorectal cancer and histologically or cytologically proven CRC metastases that occupy 50% or less of the liver parenchyma. * Patient has liver-dominant metastatic disease. Liver-dominant is defined as the majority of total tum...

Countries:United StatesCzechiaGermanyItalyNetherlandsSerbiaSpainTurkey (Türkiye)
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Competitive Landscape -Colorectal Cancer 259 trials (matched to "Refractory Metastatic Colorectal Cancer")
Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06607458lastUpdatePostDate: changed
LOWJun 2, 2026NCT06607458lastUpdatePostDate: changed
LOWJun 2, 2026NCT06607458lastUpdatePostDate: changed
LOWMay 26, 2026NCT06607458primaryCompletionDate: changed
LOWMay 24, 2026NCT06607458studyFirstPostDate: changed