Colorectal CancerNCT05818267
Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)
A study testing Regorafenib in people with Colorectal Cancer, run by Wei Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Regorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Wei Zhang, 021-31161613, weizhang2000cn@163.com
About this study
Official title: Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC) Without Imaging Progress Three Months After Second-Line Treatment
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.
- Conditions
- Colorectal Cancer
- Being tested
- Regorafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of disease control(DDC)
From second-line treatment initiation to third disease progression
Measured: 6 month
Secondary outcomes (3)
Overall Survival(OS)
Subjects were censored from the time of enrollment to the time of death from any cause, and the date of censoring was the date of the last follow-up visit if the subject's last status was alive.
Measured: 3 years
Quality-of-Life(QoL)
Quality-of-life was evaluated using the Quality-of-Life Questionnaire C30 (EORTC QLQ-C 30) developed by the European organization for research and treatment of cancer (EORTC)
Measured: 3 years
The incidence of adverse events
Adverse Events (AE) will be evaluated and graded according to NCI-CTCAE v5.0. All adverse events will be reported at length.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start26 Jun 2023
- Primary completionMar 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818267
- Sponsor's protocol ID
- RE-SUSTAIN
- Status last verified
- Jul 2023
- First submitted
- 24 Feb 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC) Without Imaging Progress Three Months After Second-Line Treatment
- ClinicalTrials.gov ID
- NCT05818267
- Acronym / sponsor ID
- RE-SUSTAIN
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wei ZhangUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: RegorafenibThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegorafenibThe 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. | Drug | Treatment group |
Primary outcome
duration of disease control(DDC)
Time frame: 6 month
From second-line treatment initiation to third disease progression
3 secondary outcomes
Overall Survival(OS)
Time frame: 3 years
Quality-of-Life(QoL)
Time frame: 3 years
The incidence of adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Colorectal Surgery in Changhai Hospital
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regorafenib in people with Colorectal Cancer, run by Wei Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of disease control(DDC) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.