Recurrent or Metastatic Colorectal CancerPhase 4NCT04810585
Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer
A Phase 4 study testing Aflibercept + FOLFIRI in people with Recurrent or Metastatic Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Based on the pervious data, aflibercept in combination with FOLFIRI is one of the effective 2nd line treatment option in advanced colorectal cancer. In this study, we prospectively assess the efficacy of 2nd line aflibercept in combination with FOLFIRI in advanced colorectal cancer in terms of progression-free… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent or Metastatic Colorectal Cancer
- What is being tested?
- Aflibercept + FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2020to Oct 2025
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is an adult, ≥ 19 years old at the time of informed consent
- Patient has histologically confirmed advanced adenocarcinoma of colon or rectum
- Patients who were failed in only one treatment with target agent (anti-EGFR Ab or anti-VEGF Ab) combined with FOLFOX
- At least one measurable disease, as defined by RECIST version 1.1
- ECOG PS of 0 to 2.
- Life expectancy ≥ 3 months.
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- Acceptable hematologic status (without growth factor support or transfusion dependency):
- ANC ≧ 1.5 x 109/L,
- Platelet count ≧100 x 109/L
- Hemoglobin ≧9.0 g/dL.
- Acceptable liver function:
- Bilirubin ≤ 1.0 x upper limit of normal(ULN)
- AST, ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN in case of liver metastasis
- Serum creatinine ≤ 1.0 x UNL
- Patients who understand study protocol and signed informed consents.
Who cannot join
- Previous therapy with other VEGFR inhibitors (other than bevacizumab) or irinotecan
- Patients who have serious underlying co-morbidities which could cause end-organ dysfunction, interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in this study. in the opinion of the Investigator
- Contraindications to the use of FOLFIRI or aflibercept
- Female patients who are pregnant or breast feeding, or male/female patients of reproductive potential who are not willing to employ effective birth control
- Patients who are unable to read the study consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University
Seoul
Joong Bae Ahn, MD, PhD, 02-2228-8134, vvswm513@yuhs.ac
Joong Bae Ahn, MD, PhD
About this study
Official title: Efficacy and Biomarker Exploration of 2nd Line Aflibercept in Combination With FOLFIRI in Advanced Colorectal Cancer
Based on the pervious data, aflibercept in combination with FOLFIRI is one of the effective 2nd line treatment option in advanced colorectal cancer. In this study, we prospectively assess the efficacy of 2nd line aflibercept in combination with FOLFIRI in advanced colorectal cancer in terms of progression-free survival. We further assess the efficacy according to the type of 1st line treatment. plasma biomarker study (HGF, VEGF-A, VEGF-D, IFN-γ, Angiopoietin-2, sICAM-1, sVCAM-1, TIMP-1, PIGF (HS), IL-6 (HS), IL-8 (HS), sNeuropilin-1, Thrombospondin-2 , Osteopontin , sVEGFR1, sVEGFR2, sVEGFR3) , overall survival (OS)OS, objective response rate (ORR), and safety are also assessed as the 2ndary objectives.
Read the detailed description
This is a prospective, multicenter, open-label, single arm study. Patients will be considered "on study" upon signing the written informed consent form (ICF). The study consists of a baseline period, followed by a treatment period, consisting of 14-day treatment cycles, which will end by a 30-day Follow-up visit, which in turn, will be followed by a post-treatment follow-up period.
Patients will be evaluated for PFS then be followed on study until death or until cut-off date for final analysis of OS has been reached, whichever comes first.
During the 21-day baseline period, all baseline procedures will have to be performed within defined timelines, including review of eligibility criteria During the treatment period, the study treatment, aflibercept combined with FOLFIRI will be administered every 2 weeks unless a definitive treatment discontinuation criterion is met. Cycle lengths may be extended in case of unresolved toxicity.
Imaging to document tumor response and progressive disease will take place every 6 weeks and will continue to be done during the follow-up period in case of early study treatment discontinuation (i.e. prior to documented progression). Once disease progression is documented, patients will be followed every 2 months for survival status and collection of data regarding further anticancer therapy, until death or until the study cutoff date, whichever comes first.
The patients will be followed for safety for a minimum of 30 days following the last administration of the study treatment (30-day Follow-up visit). Beyond this date, all study drug related AEs and all SAEs should be followed until resolution/stabilization. Study drug-related AEs brought to the attention of the investigator at any time after the 30-day Follow-up visit should be recorded in the case report form (CRF).
- Being tested
- Aflibercept + FOLFIRI
- Medical subject headings
- Recurrence, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept + FOLFIRIDrug
Day 1. Aflibercept + FOLFIRI
- aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus)
- Folinic acid: 400 mg/m2 IV infusion for over 2 hours
- Irinotecan: 150 mg/m2 IV infusion for over 1 hours
- 5-FU: 400 mg/m2 IV bolus injection for over 5 minute
- 5-FU: 2400 mg/m2 IV continuous infusion for 46 hours every 2 weeks until progression disease or death or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Aflibercept + FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
progressive disease (PD) or death, whichever occurs first. Results will be summarized by arm
- Kaplan-Meier method for survival function estimate
- Stratified Cox proportional hazard regression for hazard ratio (HR) estimate
Measured: up to 5years
Secondary outcomes (4)
Overall Survival (OS)
Measured: up to 5years
ORR (Objective Response Rate)
Measured: up to 5years
Incidence of Adverse events (Safety)/ vital sign(Safety)/ ECOG PS(Safety)
Measured: up to 5years
Prognostic or Predictive Biomarker for Aflibercept (plasma biomarker)
Measured: up to 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start20 Apr 2020
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joong Bae Ahn, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810585
- Sponsor's protocol ID
- 4-2019-1285
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Biomarker Exploration of 2nd Line Aflibercept in Combination With FOLFIRI in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04810585
- Acronym / sponsor ID
- 4-2019-1285
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 23 Mar 2021 (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.
Based on the pervious data, aflibercept in combination with FOLFIRI is one of the effective 2nd line treatment option in advanced colorectal cancer. In this study, we prospectively assess the efficacy of 2nd line aflibercept in combination with FOLFIRI in advanced colorectal cancer in terms of progression-free survival. We further assess the efficacy according to the type of 1st line treatment. plasma biomarker study (HGF, VEGF-A, VEGF-D, IFN-γ, Angiopoietin-2, sICAM-1, sVCAM-1, TIMP-1, PIGF (HS), IL-6 (HS), IL-8 (HS), sNeuropilin-1, Thrombospondin-2 , Osteopontin , sVEGFR1, sVEGFR2, sVEGFR3) , overall survival (OS)OS, objective response rate (ORR), and safety are also assessed as the 2ndary objectives.
Detailed description
This is a prospective, multicenter, open-label, single arm study. Patients will be considered "on study" upon signing the written informed consent form (ICF). The study consists of a baseline period, followed by a treatment period, consisting of 14-day treatment cycles, which will end by a 30-day Follow-up visit, which in turn, will be followed by a post-treatment follow-up period.
Patients will be evaluated for PFS then be followed on study until death or until cut-off date for final analysis of OS has been reached, whichever comes first.
During the 21-day baseline period, all baseline procedures will have to be performed within defined timelines, including review of eligibility criteria During the treatment period, the study treatment, aflibercept combined with FOLFIRI will be administered every 2 weeks unless a definitive treatment discontinuation criterion is met. Cycle lengths may be extended in case of unresolved toxicity.
Imaging to document tumor response and progressive disease will take place every 6 weeks and will continue to be done during the follow-up period in case of early study treatment discontinuation (i.e. prior to documented progression). Once disease progression is documented, patients will be followed every 2 months for survival status and collection of data regarding further anticancer therapy, until death or until the study cutoff date, whichever comes first.
The patients will be followed for safety for a minimum of 30 days following the last administration of the study treatment (30-day Follow-up visit). Beyond this date, all study drug related AEs and all SAEs should be followed until resolution/stabilization. Study drug-related AEs brought to the attention of the investigator at any time after the 30-day Follow-up visit should be recorded in the case report form (CRF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Aflibercept + FOLFIRI |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient is an adult, ≥ 19 years old at the time of informed consent
- Patient has histologically confirmed advanced adenocarcinoma of colon or rectum
- Patients who were failed in only one treatment with target agent (anti-EGFR Ab or anti-VEGF Ab) combined with FOLFOX
- At least one measurable disease, as defined by RECIST version 1.1
- ECOG PS of 0 to 2.
Key exclusion criteria (5 listed)
- Previous therapy with other VEGFR inhibitors (other than bevacizumab) or irinotecan
- Patients who have serious underlying co-morbidities which could cause end-organ dysfunction, interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in this study. in the opinion of the Investigator
- Contraindications to the use of FOLFIRI or aflibercept
- Female patients who are pregnant or breast feeding, or male/female patients of reproductive potential who are not willing to employ effective birth control
- Patients who are unable to read the study consent
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 |
|---|---|---|
| Aflibercept + FOLFIRIDay 1. Aflibercept + FOLFIRI * aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus) * Folinic acid: 400 mg/m2 IV infusion for over 2 hours * Irinotecan: 150 mg/m2 IV infusion for over 1 hours * 5-FU: 400 mg/m2 IV bolus injection for over 5 minute * 5-FU: 2400 mg/m2 IV continuous infusion for 46 hours every 2 weeks until progression disease or death or unacceptable toxicity | Drug | Treatment |
Primary outcome
Progression free survival
Time frame: up to 5years
progressive disease (PD) or death, whichever occurs first. Results will be summarized by arm * Kaplan-Meier method for survival function estimate * Stratified Cox proportional hazard regression for hazard ratio (HR) estimate
4 secondary outcomes
Overall Survival (OS)
Time frame: up to 5years
ORR (Objective Response Rate)
Time frame: up to 5years
Incidence of Adverse events (Safety)/ vital sign(Safety)/ ECOG PS(Safety)
Time frame: up to 5years
Prognostic or Predictive Biomarker for Aflibercept (plasma biomarker)
Time frame: up to 5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Joong Bae Ahn, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept + FOLFIRI in people with Recurrent or Metastatic Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
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 15 inclusion and 5 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 23 Mar 2021. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Joong Bae Ahn, MD, PhD (82-2-2228-8134, vvswm513@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: up to 5years). 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 23 Mar 2021.