Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer
Efficacy and Safety of Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy for Refractory Metastatic Colorectal Cancer: a Retrospective Study
1 other identifier
observational
90
1 country
1
Brief Summary
This study is a retrospective study to compare the efficacy and safety between trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) with TAS-102 monotherapy in refractory metastatic colorectal cancer (mCRC) from November 2020 to October 2022 at the Hunan Cancer Hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedFirst Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedMay 22, 2023
May 1, 2023
2 years
May 11, 2023
May 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival defined as the observed time elapsed between the date of commencement of treatment and the date of death due to any cause
Approximately 12 months
Secondary Outcomes (4)
Progression-free survival (PFS)
Approximately 12 months
Overall response rate (ORR)
Approximately 12 months
Disease control rate (DCR)
Approximately 12 months
Treatment-Related Adverse Events (TRAE)
Approximately 12 months
Study Arms (2)
TAS-102 plus BEV group
In TAS-102 plus BEV group, Patients received TAS-102 (35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days) and bevacizumab (5 mg /kg, intravenously, on days 1 and 15, every 28 days). Bevacizumab was approved to be a 30-minute intravenous infusion before TAS-102.
TAS-102 monotherapy group
In TAS-102 monotherapy group, TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days were given to patients.
Interventions
TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days
Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days
Eligibility Criteria
Study population were the patients treated with at least 1 cycle of TAS-102 with or without BEV in patients suffering refractory mCRC from November 2020 to October 2022 at the Hunan Cancer Hospital.
You may qualify if:
- Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
- Has measurable or non-measurable disease as defined by RECIST version 1.1 4.Is able to swallow oral tablets. 5.Estimated life expectancy ≥12 weeks. 6.Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 7. Has adequate organ function.
You may not qualify if:
- Pregnancy, lactating female or possibility of becoming pregnant during the study.
- Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
- Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer hospital
Changsha, Hunan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 22, 2023
Study Start
November 1, 2020
Primary Completion
October 31, 2022
Study Completion
April 30, 2023
Last Updated
May 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- please contact the principal investigator of this study or correspondence author.
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for principal investigator or correspondence author\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.