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Trial Title:
Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)
NCT ID:
NCT05818267
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Regorafenib
Description:
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.
Arm group label:
Treatment group
Summary:
Regorafenib in third-line treatment of metastatic colorectal cancer(mCRC) significantly
prolongs the survival of patients, and its advancement has a sensitizing effect on
postline chemotherapy and thus improves the prognosis of patients. Therefore, the present
study was designed to include patients who achieved stable disease/partial
response(SD/PR) after 3 months of second-line therapy and advance regorafenib to
investigate the role of advance regorafenib in prolonging progression-free survival,
prolonging the efficacy of overall survival, safety, and quality of life in patients with
mCRC compared with standard second-line and third-line therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with histologically or cytologically confirmed metastatic colorectal cancer
who have measurable metastatic disease according to the Resolute Efficacy Criteria
for Solid Tumors (RECIST) version 1.1.
- 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:
- Concurrent primary tumors of other types.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Colorectal Surgery in Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Zhang
Phone:
021-31161613
Email:
weizhang2000cn@163.com
Start date:
June 26, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
Wei Zhang
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05818267
