Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)
NCT ID: NCT05818267
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2023-06-26
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer
NCT04110093
Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer
NCT05942768
Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Metastatic Colorectal Cancer
NCT03158610
Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC
NCT05970705
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
NCT01584830
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group
The drug dose that taken by the subject is gradually increased to the maximum dose tolerated by the patient according to individualization. Specifically, the initial dose of 80 mg/day was gradually increased to 120 mg/day (80 mg/day in the first week, 120 mg/day in the second week, and a maximum tolerated dose of 160 mg/day). The maximum tolerated dose is 160 mg/day. The dose is administered once daily in a 4-week cycle (3 weeks of dosing and 1 week of rest) and the maximum dose achieved in the first treatment cycle is maintained.At the discretion of the investigator, regorafenib may be delayed or discontinued. Dose adjustments and interruptions due to toxicity are made according to the recommendations specified in the protocol.
Regorafenib
The drug dose that taken by the subject is gradually increased to the maximum dose tolerated by the patient according to individualization. Specifically, the initial dose of 80 mg/day was gradually increased to 120 mg/day (80 mg/day in the first week, 120 mg/day in the second week, and a maximum tolerated dose of 160 mg/day). The maximum tolerated dose is 160 mg/day. The dose is administered once daily in a 4-week cycle (3 weeks of dosing and 1 week of rest) and the maximum dose achieved in the first treatment cycle is maintained.At the discretion of the investigator, regorafenib may be delayed or discontinued. Dose adjustments and interruptions due to toxicity are made according to the recommendations specified in the protocol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Regorafenib
The drug dose that taken by the subject is gradually increased to the maximum dose tolerated by the patient according to individualization. Specifically, the initial dose of 80 mg/day was gradually increased to 120 mg/day (80 mg/day in the first week, 120 mg/day in the second week, and a maximum tolerated dose of 160 mg/day). The maximum tolerated dose is 160 mg/day. The dose is administered once daily in a 4-week cycle (3 weeks of dosing and 1 week of rest) and the maximum dose achieved in the first treatment cycle is maintained.At the discretion of the investigator, regorafenib may be delayed or discontinued. Dose adjustments and interruptions due to toxicity are made according to the recommendations specified in the protocol.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Received standard second-line therapy, achieved stable disease(SD) and above by recist1.1 tumor assessment and maintained for 3 months.
* Eastern Oncology Collaborative Group(ECOG) physical status of 0 or 1 at trial entry and life expectancy ≥ 3 months.
* No bone marrow suppression and normal heart, lung, liver and kidney function.
* Voluntary participation in research.
Exclusion Criteria
* MSI-H/dMMR type mCRC patients.
* Heart, liver, kidney, bone marrow insufficiency or mental abnormalities.
* Intolerant to treatment methods
* Concurrent participants in other clinical trials.
* Pregnant or lactating women.
* Patients deemed unsuitable for study participation by the remaining investigators.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wei Zhang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wei Zhang
Profrssor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RE-SUSTAIN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.