OncologyPhase 4VASCATAQNCT04813913
VASCular Impact of Angiogenic Treatment in Patients With Advanced Colorectal Cancer
A Phase 4 study testing Bevacizumab in combination with chemotherapy based on fluoropyrimidine IV in people with Oncology, run by University Hospital, Rouen at 1 site in France.
Trial summary
Antiangiogenic treatments are used in many tumor locations such as metastatic colorectal cancer (mCRC) with a significant improvement in carcinological results on overall survival and / or progression-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Bevacizumab in combination with chemotherapy based on fluoropyrimidine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2019to 21 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at least 18 years old,
- Patient with colorectal cancer of the adenocarcinoma type, stage IV, histologically confirmed, mutated or wild tumor RAS status (exons 2, 3 and 4 of the KRAS and NRAS genes), mutated or wild BRAF status, naive in antineoplastic treatment
- Patient eligible to start systemic carcinological treatment including bevacizumab in combination with chemotherapy based on IV fluoropyrimidine,
- General condition WHO grade less than or equal to 3,
- Life expectancy greater than 4 months,
- Patient who has read and understood the information letter and signed the consent form,
- Patient affiliated to a social security scheme,
- Effective contraception (see WHO definition) in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmatory diagnosis should be obtained (amenorrhea not medically induced for at least 12 months before the inclusion visit).
Who cannot join
- Previous exposure to anti-VEGF,
- Exposure to treatment for metastatic disease in the 12 months prior to inclusion,
- Other histologically proven neoplasia not considered in complete remission or considered in complete remission for less than two years,
- Bilateral carotid breath,
- Absence of peripheral pulse of the two upper limbs,
- Contraindication to AVASTIN 25 mg / ml concentrate for solution for infusion:
Show all 24Show fewer
- Hypersensitivity to the active substance or to any of the excipients,
- Hypersensitivity to Chinese hamster ovarian cell products or other human or humanized recombinant antibodies,
- Patients:
- having undergone a major surgical intervention in the 28 days preceding the inclusion or as long as the surgical wound is not completely healed,
- Unhealed ulcer or wound,
- having uncontrolled pre-existing hypertension (PAS> or = 170 mm Hg after three repeated measurements at rest),
- having a history of arterial thromboembolism (transient ischemic attack (TIA), cardiovascular accident (stroke) or recent (<6 months) and / or symptomatic myocardial infarction (MI)
- having had an invasive dental procedure in the 28 days preceding inclusion,
- with known proteinuria> 2g / 24h or in whom proteinuria> 2g / 24h is discovered in the case of a positive urine strip 3+ for proteins (excluding urinary tract infection),
- on aspirin> 325 mg / d,
- with a colonic prosthesis in place,
- Systemic treatment with anti-EGFR monoclonal antibodies,
- Presence or history of lymphedema of the bilateral upper limbs,
- Patient with poor understanding of spoken or written French,
- Patient deprived of liberty by an administrative or judicial decision or patient placed under the protection of justice, under guardianship or curatorship,
- Pregnant or lactating woman or wishing to breastfeed within 6 months after the last administration of the treatment,
- Patient participating in another drug trial / having participated in another drug trial within 30 days of inclusion,
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for his participation
Trial locations and contacts
1 site in 1 country.
About this study
Antiangiogenic treatments are used in many tumor locations such as metastatic colorectal cancer (mCRC) with a significant improvement in carcinological results on overall survival and / or progression-free survival. However, their use is characterized by an increase in side effects and in particular cardiovascular effects such as high blood pressure (hypertension). One of the main classes of antiangiogens used in this indication is that of monoclonal antibodies, the leader of which is bevacizumab (Avastin®, Roche, Bale, Switzerland). Bevacizumab works by inhibiting endothelial vascular growth factor-dependent neoangiogenesis (vascular endothelial growth factor VEGF). In the reference studies, the inhibition of VEGF, whether extracellular (monoclonal antibody directed against VEGFA) or intracellular (receptor inhibitors with tyrosine kinase activity), induces hypertension of all grades, observed in 25% to 40 % of patients including 8 to 17% of severe grades (≥ grade 3 NCI-CTCAE). In terms of pathophysiology, inhibition of VEGFA results in a decrease in the availability of nitric oxide (NO) at the endothelial level and the appearance of arteriolar rarefaction. This induces an increase in peripheral resistance responsible ultimately for an increase in blood pressure. The occurrence of hypertension induced by anti-VEGF treatment seems to be predictive of the carcinological response in certain oncological situations such as metastatic breast cancer9, glioblastoma and mRCC. Furthermore, it has also been shown that there is an early attack on the elastic conductance arteries (branches of the aorta and its main ones) characterized by an increase in their rigidity in patients exposed to a VEGF receptor inhibitor with tyrosine activity. kinase or bevacizumab. This increase, whose poor prognostic impact is known at the cardiovascular level is largely independent of the rise in blood pressure and reflects a direct toxicity of treatments at the level of the artery wall. This increase in rigidity, refused when the pressure rises, would be predictive of a low carcinological response rate at 6 months. However, these data are based on populations that are heterogeneous in terms of carcinology and the position prior to or concomitant with other antineoplastic treatments.
In this context, the evaluation of arterial stiffness in the same patient population would make it possible to better define the involvement of the conductive arteries in a clearly defined clinical situation. Joint measurements of the plasma concentration of the treatment as well as those of factors derived from the endothelium and circulating tumor markers which, to our knowledge, have never been carried out in these patients, would make it possible to better specify the mechanisms of involvement and the links between exposure, arterial toxicity and carcinologic efficacy of bevacizumab. Of course, in order to assess more precisely the inherent impact of chemotherapy on the conductance arteries, the evolution of arterial stiffness must take into account the possible effects in patients receiving, for essentially clinical and biological reasons, systemic treatment without antiangiogenic.
- Conditions
- Oncology
- Being tested
- Bevacizumab in combination with chemotherapy based on fluoropyrimidine IV
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab in combination with chemotherapy based on fluoropyrimidine IVDrug
Enrollement of major patient with colorectal cancer of the adenocarcinoma type, stage IV, histologically confirmed, naive in antineoplastic treatment and eligible to start a systemic carcinological treatment comprising bevacizumab in combination with chemotherapy based on fluoropyrimidine IV. The main objective is to show that there is an increase in the stiffness of the carotid artery at 4 months in patients with stage IV colorectal cancer exposed to bevacizumab.
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | bevacizumab in combination with IV fluoropyrimidine chemotherapy. Receives: Drug: Bevacizumab in combination with chemotherapy based on fluoropyrimidine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in carotid stiffness between baseline and at 4 months of bevacizumab treatment.
Difference in carotid stiffness estimated by the delta of the pulse wave velocity calculated by an applanation tonometry and an ultrasound at the level of the common carotid artery, between baseline and at 4 months of bevacizumab treatment.
Measured: Through study completion, an average of 4 months
Secondary outcomes (7)
Difference of central arterial pressures between baseline and at 4 months of bevacizumab treatment
Differences of central arterial pressures, of aortic stiffness, calculated by a flattening tonometry between the values before exposure and at 4 months of exposure to bevacizumab. Differences between the distensibility of the common carotid artery, calculated from the carotid diameters during the heart beat and estimated by carotid echotracking before, at 4 months of bevacizumab treatment
Measured: Through study completion, an average of 4 months
Difference of central arterial pressures between baseline and at 1 month of bevacizumab treatment
Differences of central arterial pressures, of aortic stiffness, calculated by a flattening tonometry between the values before exposure and at 1 month of exposure to bevacizumab. Differences between the distensibility of the common carotid artery, calculated from the carotid diameters during the heart beat and estimated by carotid echotracking before, at 1 month of bevacizumab treatment
Measured: 1 month
Difference of peripheral arterial pressures between baseline and at 4 months of bevacizumab treatment
Differences of peripheral arterial pressures, of aortic stiffness, calculated by a flattening tonometry between the values before exposure and at 4 months of exposure to bevacizumab. Differences between the distensibility of the common carotid artery, calculated from the carotid diameters during the heart beat and estimated by carotid echotracking before, at 4 months of bevacizumab treatment
Measured: 4 months
Difference of peripheral arterial pressures between baseline and at 1 month of bevacizumab treatment
Differences of peripheral arterial pressures, of aortic stiffness, calculated by a flattening tonometry between the values before exposure and at 1 month of exposure to bevacizumab. Differences between the distensibility of the common carotid artery, calculated from the carotid diameters during the heart beat and estimated by carotid echotracking before, at 1 month of bevacizumab treatment
Measured: 1 month
The evolution of circulating concentrations of markers of endothelial function (nitric oxide [NO], epoxyeicosatrienoic acids [EETs], sVE-cadherin),
Differences in plasma concentrations of NO, EETs and sVE-cadherin before exposure and at 1 and 4 months of bevacizumab treatment.
Measured: 1 and 4 months
Changes in the concentrations of bevacizumab and its autoantibody, of a circulating tumor marker, circulating markers of hypoxia and angiogenesis (HIF1alpha, sVEGFR2, VEGF-A) and their correlations with the proportion of responders,
Correlations between all of these parameters and the proportion of responder or stable patients at 12 months. A patient is considered to be responder or stable or without progression if there is neither a CT argument according to RECIST 1.1 criteria, nor a clinical argument for tumor progression.
Measured: 12 months
Progression-free survival at 12 months.
12-month progression-free survival.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start5 May 2019
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813913
- Sponsor's protocol ID
- 2017/0184 HP
- Acronym
- VASCATAQ
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VASCular Impact of Angiogenic Treatment in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04813913
- Acronym / sponsor ID
- VASCATAQ / 2017/0184 HP
- Conditions
- Oncology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 24 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.
Antiangiogenic treatments are used in many tumor locations such as metastatic colorectal cancer (mCRC) with a significant improvement in carcinological results on overall survival and / or progression-free survival. However, their use is characterized by an increase in side effects and in particular cardiovascular effects such as high blood pressure (hypertension). One of the main classes of antiangiogens used in this indication is that of monoclonal antibodies, the leader of which is bevacizumab (Avastin®, Roche, Bale, Switzerland). Bevacizumab works by inhibiting endothelial vascular growth factor-dependent neoangiogenesis (vascular endothelial growth factor VEGF). In the reference studies, the inhibition of VEGF, whether extracellular (monoclonal antibody directed against VEGFA) or intracellular (receptor inhibitors with tyrosine kinase activity), induces hypertension of all grades, observed in 25% to 40 % of patients including 8 to 17% of severe grades (≥ grade 3 NCI-CTCAE). In terms of pathophysiology, inhibition of VEGFA results in a decrease in the availability of nitric oxide (NO) at the endothelial level and the appearance of arteriolar rarefaction. This induces an increase in peripheral resistance responsible ultimately for an increase in blood pressure. The occurrence of hypertension induced by anti-VEGF treatment seems to be predictive of the carcinological response in certain oncological situations such as metastatic breast cancer9, glioblastoma and mRCC. Furthermore, it has also been shown that there is an early attack on the elastic conductance arteries (branches of the aorta and its main ones) characterized by an increase in their rigidity in patients exposed to a VEGF receptor inhibitor with tyrosine activity. kinase or bevacizumab. This increase, whose poor prognostic impact is known at the cardiovascular level is largely independent of the rise in blood pressure and reflects a direct toxicity of treatments at the level of the artery wall. This increase in rigidity, refused when the pressure rises, would be predictive of a low carcinological response rate at 6 months. However, these data are based on populations that are heterogeneous in terms of carcinology and the position prior to or concomitant with other antineoplastic treatments.
In this context, the evaluation of arterial stiffness in the same patient population would make it possible to better define the involvement of the conductive arteries in a clearly defined clinical situation. Joint measurements of the plasma concentration of the treatment as well as those of factors derived from the endothelium and circulating tumor markers which, to our knowledge, have never been carried out in these patients, would make it possible to better specify the mechanisms of involvement and the links between exposure, arterial toxicity and carcinologic efficacy of bevacizumab. Of course, in order to assess more precisely the inherent impact of chemotherapy on the conductance arteries, the evolution of arterial stiffness must take into account the possible effects in patients receiving, for essentially clinical and biological reasons, systemic treatment without antiangiogenic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: Bevacizumab in combination with chemotherapy based on fluoropyrimidine IVbevacizumab in combination with IV fluoropyrimidine chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient at least 18 years old,
- Patient with colorectal cancer of the adenocarcinoma type, stage IV, histologically confirmed, mutated or wild tumor RAS status (exons 2, 3 and 4 of the KRAS and NRAS genes), mutated or wild BRAF status, naive in antineoplastic treatment
- Patient eligible to start systemic carcinological treatment including bevacizumab in combination with chemotherapy based on IV fluoropyrimidine,
- General condition WHO grade less than or equal to 3,
- Life expectancy greater than 4 months,
Key exclusion criteria (24 listed)
- Previous exposure to anti-VEGF,
- Exposure to treatment for metastatic disease in the 12 months prior to inclusion,
- Other histologically proven neoplasia not considered in complete remission or considered in complete remission for less than two years,
- Bilateral carotid breath,
- Absence of peripheral pulse of the two upper limbs,
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 |
|---|---|---|
| Bevacizumab in combination with chemotherapy based on fluoropyrimidine IVEnrollement of major patient with colorectal cancer of the adenocarcinoma type, stage IV, histologically confirmed, naive in antineoplastic treatment and eligible to start a systemic carcinological treatment comprising bevacizumab in combination with chemotherapy based on fluoropyrimidine IV. The main objective is to show that there is an increase in the stiffness of the carotid artery at 4 months in patients with stage IV colorectal cancer exposed to bevacizumab. | Drug | bevacizumab |
Primary outcome
Difference in carotid stiffness between baseline and at 4 months of bevacizumab treatment.
Time frame: Through study completion, an average of 4 months
Difference in carotid stiffness estimated by the delta of the pulse wave velocity calculated by an applanation tonometry and an ultrasound at the level of the common carotid artery, between baseline and at 4 months of bevacizumab treatment.
7 secondary outcomes
Difference of central arterial pressures between baseline and at 4 months of bevacizumab treatment
Time frame: Through study completion, an average of 4 months
Difference of central arterial pressures between baseline and at 1 month of bevacizumab treatment
Time frame: 1 month
Difference of peripheral arterial pressures between baseline and at 4 months of bevacizumab treatment
Time frame: 4 months
Difference of peripheral arterial pressures between baseline and at 1 month of bevacizumab treatment
Time frame: 1 month
The evolution of circulating concentrations of markers of endothelial function (nitric oxide [NO], epoxyeicosatrienoic acids [EETs], sVE-cadherin),
Time frame: 1 and 4 months
Changes in the concentrations of bevacizumab and its autoantibody, of a circulating tumor marker, circulating markers of hypoxia and angiogenesis (HIF1alpha, sVEGFR2, VEGF-A) and their correlations with the proportion of responders,
Time frame: 12 months
Progression-free survival at 12 months.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bevacizumab in combination with chemotherapy based on fluoropyrimidine IV in people with Oncology, run by University Hospital, Rouen at 1 site in France.
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 8 inclusion and 24 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: finished, as of the sponsor's last update on 6 Feb 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in carotid stiffness between baseline and at 4 months of bevacizumab treatment. (time frame: Through study completion, an average of 4 months). 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 6 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.