Colorectal CancerNCT04431791
Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer
An observational study of Colorectal Cancer, run by Peking University at 1 site in China.
Trial summary
This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Regorafenib and Fruquintinib
- Type of treatment
- Pill or oral medicine
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2020to 1 Feb 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with signing the informed consent, would be enrolled when their gastrointestinal physician prescribed to receive regorafenib or fruquintinib after second-line according the condition.
Who may be able to join
- signed and dated informed consent.
- Diagnosis of histologically confirmed colorectal cancer, stage IV.
- after second-line therapy.
- gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.
Who cannot join
- received regorafenib or fruquintinib before third-line therapy.
- the clinicopathological characteristics and previous therapy were unknown.
- regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Li, MD, 86-010-88196088, oncogene@163.com
About this study
Official title: A Single-center，Observational，Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies
This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.
- Conditions
- Colorectal Cancer
- Being tested
- Regorafenib, Fruquintinib
- Keywords
- Targeted therapy, TTF, OS, PFS, AE
- 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
oral regorafenib
FruquintinibDrug
oral fruquintinib
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib | Not described Receives: Drug: Regorafenib | |
| Fruquintinib | Not described Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Treatment Failure
the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
Measured: every month, up to discontinuation of treatment for any reason.
Secondary outcomes (3)
Overall survival
the time from first dose to the death for any cause.
Measured: from enrollment of the first subject until the database cut-off approximately 6 months later.
Progression-free survival
the time from first dose to disease progression.
Measured: from enrollment of the first subject until the database cut-off approximately 6 months later.
Incidence of adverse events（AEs）
percentage of patients with AEs according to CTCAE 4.03
Measured: from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start25 May 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Feb 2022 (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.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431791
- Sponsor's protocol ID
- Reg vs Fru
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center，Observational，Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies
- ClinicalTrials.gov ID
- NCT04431791
- Acronym / sponsor ID
- Reg vs Fru
- Conditions
- Colorectal Cancer
- Keywords
- Targeted therapy, TTF, OS, PFS, AE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 16 Jun 2020 (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.
This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regorafenib | – | Drug: Regorafenib |
| Fruquintinib | – | Drug: Fruquintinib |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with signing the informed consent, would be enrolled when their gastrointestinal physician prescribed to receive regorafenib or fruquintinib after second-line according the condition.
Key inclusion criteria (4 listed)
- signed and dated informed consent.
- Diagnosis of histologically confirmed colorectal cancer, stage IV.
- after second-line therapy.
- gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.
Key exclusion criteria (3 listed)
- received regorafenib or fruquintinib before third-line therapy.
- the clinicopathological characteristics and previous therapy were unknown.
- regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.
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 |
|---|---|---|
| Regorafeniboral regorafenib | Drug | Regorafenib |
| Fruquintiniboral fruquintinib | Drug | Fruquintinib |
Primary outcome
Time To Treatment Failure
Time frame: every month, up to discontinuation of treatment for any reason.
the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
3 secondary outcomes
Overall survival
Time frame: from enrollment of the first subject until the database cut-off approximately 6 months later.
Progression-free survival
Time frame: from enrollment of the first subject until the database cut-off approximately 6 months later.
Incidence of adverse events（AEs）
Time frame: from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Peking University 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 4 inclusion and 3 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 16 Jun 2020. 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?
Time To Treatment Failure (time frame: every month, up to discontinuation of treatment for any reason.). 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 16 Jun 2020.