18 and older, any sex, with Refractory Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS)Primary· From date of randomization to the death due to any cause or cut-off date, whichever comes first (maximum duration: up to 20 months)
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method.
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
10.78
9.36 – 11.83
Trifluridine/Tipiracil
7.46
6.34 – 8.57
Survival Probability at 6 MonthsPrimary· From date of randomization until 6 months post treatment
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 6 months was reported.
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.77
0.72 – 0.82
Trifluridine/Tipiracil
0.61
0.55 – 0.67
Survival Probability at 12 MonthsPrimary· From date of randomization until 12 months post treatment
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 12 months was reported.
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.43
0.36 – 0.49
Trifluridine/Tipiracil
0.30
0.24 – 0.36
Survival Probability at 18 MonthsPrimary· From date of randomization until 18 months post treatment
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 18 months was reported.
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.28
0.19 – 0.37
Trifluridine/Tipiracil
0.15
0.09 – 0.22
Progression Free Survival (PFS)Secondary· From randomization to the date of radiological tumour progression or death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)
PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
5.55
4.50 – 5.88
Trifluridine/Tipiracil
2.40
2.07 – 3.22
Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 MonthsSecondary· From randomization until 3, 6, 9, and 12 months post treatment
PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported.
At 3 Months
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.73
0.67 – 0.78
Trifluridine/Tipiracil
0.45
0.39 – 0.51
At 6 Months
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.43
0.37 – 0.49
Trifluridine/Tipiracil
0.16
0.11 – 0.21
At 9 Months
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.28
0.22 – 0.34
Trifluridine/Tipiracil
0.05
0.03 – 0.09
At 12 Months
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.16
0.12 – 0.21
Trifluridine/Tipiracil
0.01
0.00 – 0.03
Overall Response Rate (ORR)Secondary· From the date of randomization to the date of documentation of progression or death due to any cause or data cut-off, whichever occurred first (i.e., up to 20 months)
Objective response was defined as percentage of participants who achieved complete response (CR) or partial response (PR) according to the RECIST version 1.1 and using investigator's tumour assessment. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
6.10
3.45 – 9.86
Trifluridine/Tipiracil
1.22
0.25 – 3.52
Percentage of Participants With Disease ControlSecondary· From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)
Disease control is defined as percentage of participants who achieved CR or PR, or stable disease (SD) as per RECIST 1.1 and using investigator's tumour assessment from the date of randomization to until disease progression or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither suffi
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
69.51
63.35 – 75.2
Trifluridine/Tipiracil
41.87
35.63 – 48.31
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)Secondary· From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months)
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE peri
TEAE
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
241
Trifluridine/Tipiracil
241
TESAE
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
66
Trifluridine/Tipiracil
79
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in Sub-scale Scores - Kaplan-Meier AnalysisSecondary· Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months)
EORTC QLQ-C30: 30 item questionnaires with 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw sco
Physical functioning
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
8.97
8.15 – 11.83
Trifluridine/Tipiracil
4.50
3.71 – 5.62
Role functioning
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
8.57
7.49 – 10.94
Trifluridine/Tipiracil
4.40
3.78 – 5.06
Emotional functioning
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
9.95
8.51 – 12.12
Trifluridine/Tipiracil
5.85
4.70 – 6.60
Cognitive functioning
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
9.36
8.34 – 12.25
Trifluridine/Tipiracil
4.73
4.07 – 6.11
Social functioning
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
8.97
7.85 – 11.86
Trifluridine/Tipiracil
4.93
4.14 – 5.88
Fatigue
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
8.21
6.11 – 9.95
Trifluridine/Tipiracil
4.04
3.19 – 4.83
Nausea and vomiting
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
9.36
8.51 – 11.86
Trifluridine/Tipiracil
5.06
4.27 – 6.31
Pain
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
8.57
6.96 – 10.41
Trifluridine/Tipiracil
4.34
3.29 – 5.16
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in the Global Health Status Score - Kaplan-Meier AnalysisSecondary· Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months)
EORTC QLQ-C30: 30 item questionnaires composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/QOL subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to line
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
8.54
7.49 – 10.94
Trifluridine/Tipiracil
4.70
4.01 – 5.78
Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value at Specified TimepointsSecondary· Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better hea
Cycle 1
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
0.004
± 0.125
Trifluridine/Tipiracil
0.001
± 0.163
Cycle 2
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
-0.003
± 0.114
Trifluridine/Tipiracil
-0.030
± 0.153
Cycle 3
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
-0.014
± 0.107
Trifluridine/Tipiracil
0.002
± 0.188
Cycle 4
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
-0.016
± 0.111
Trifluridine/Tipiracil
-0.014
± 0.209
Cycle 5
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
-0.003
± 0.101
Trifluridine/Tipiracil
0.004
± 0.120
Cycle 6
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
-0.010
± 0.112
Trifluridine/Tipiracil
-0.003
± 0.094
Cycle 7
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
-0.007
± 0.078
Trifluridine/Tipiracil
0.002
± 0.105
Cycle 8
Group
Value
95% CI
Trifluridine/Tipiracil + Bevacizumab
-0.016
± 0.097
Trifluridine/Tipiracil
-0.028
± 0.109
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious AEs and Other AEs: From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months); All-cause mortality: from baseline (Cycle 1 Day 1) up to end of the study (i.e., up to 33.6 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Trifluridine/Tipiracil + Bevacizumab
Serious: 66/246 (27%)
Deaths: 208/246
Trifluridine/Tipiracil
Serious: 79/246 (32%)
Deaths: 224/246
Serious adverse events (136 terms)
Reaction
System
Trifluridine/Tipiracil + B…
Trifluridine/Tipiracil
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
COVID-19
Infections and infestations
—
—
Jaundice
Hepatobiliary disorders
—
—
Hepatic failure
Hepatobiliary disorders
—
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Fatigue
General disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Jaundice cholestatic
Hepatobiliary disorders
—
—
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06195111 — A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)
· not yet recruiting
NCT05965531 — Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
· Phase 2
· recruiting
NCT05970705 — Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC
· Phase 2
· recruiting
NCT05223673 — Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single A
· Phase 3
· terminated
NCT04894123 — Cardiovascular Events From Trifluridine/Tipiracil +/- Oxaliplatin in Colorectal/Oesogastric Adenocarcinoma Patients
· Phase 2
· terminated
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· Phase 3
· recruiting
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· Phase 3
· active not recruiting
NCT05967689 — A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR
· Phase 2
· recruiting
NCT05765734 — A Study of TAS3351 in NSCLC Patients With EGFRmt
· Phase 1
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NCT05403450 — A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Partici
· Phase 1
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Taiho Oncology, Inc.
Last refreshed: 24 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04737187.