Colorectal NeoplasmsPhase 2BEVIACNCT01677884
Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy
A Phase 2 study testing Bevacizumab, Capecitabine and Irinotecan in people with Colorectal Neoplasms, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Bevacizumab, Capecitabine and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Feb 2016
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases)
- Isolated (no extra-hepatic metastasis, primary tumor resected)
- No access to curative hepatectomy (R0 resection foreseeable or not leaving less than 30% residual non-tumor liver normally vascularized), or requiring complex hepatectomy, very large (5 or more segments) and / or risked (class II CPP)
- which at least one measurable by RECIST (>2 cm, or >1 cm if Computed tomography (CT) spiraled)
- Or extra-hepatic disease of small size potentially accessible to a resection (one or two lung metastases, lymphadenopathy localized accessible to curative resection)
- colon or rectal primary tumor : resected or asymptomatic
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- Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab
- Age >18 years <75 years
- Performance status WHO 0 or 1
- Life expectancy >3 months
- Bilirubin <1.5 times the upper limit of normal (N), ASAT and ALAT <5N, creatinine <1.5 N neutrophils >1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin >9g/dL. Patients may be included even if they were transfused
- CT (or MRI) reference for the measurement of metastases performed within 28 days before the first treatment cycle
- Information of the patient or legal representative signing the informed consent
- Affiliated to a social security system
Who cannot join
- Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage, major rectal syndrome)
- Extra-hepatic metastases other than small size disease potentially accessible after resection
- Grade 3-4 allergy to one of the treatment compounds
- Two lines of prior chemotherapy. One line is allowed for metastatic disease but must have been started more than 6 months after completion of adjuvant treatment.
- Participation during or within 30 days before study to another therapeutic trial with an experimental molecule
- Concomitant cancer systemic treatment using immunotherapy, chemotherapy or hormone
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- Symptomatic CHD or myocardial infarction within 6 months prior entry into the study, cardiac arrhythmia uncontrolled despite treatment
- Uncontrolled hypertension (blood pressure >150/100 mm Hg despite hypertensive treatment)
- Heart Failure >Grade II of the New York Heart Association (NYHA) (class II-III-IV)severe renal failure
- History and / or presence of bleeding disorders and/or thrombotic <6 months
- Uncontrolled Serious illness, uncontrolled active infection or other serious underlying condition which may prevent the patient to receive treatment
- Pregnancy (or positive pregnancy test at baseline), lactation or no contraception effective for men or women of childbearing age
- Occlusion or sub-bowel obstruction or history of inflammatory bowel disease
- Other cancer within 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or skin basal-cell carcinoma properly treated)
- Legal inability (persons deprived of liberty or under guardianship)
- Inability to sign the consent or submit to medical test for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy in Hepatic Metastases of Metastatic Colorectal Cancer: a Phase II Multicentric Study With Patients in Progression After First Line Systemic Chemotherapy
The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)
- Conditions
- Colorectal Neoplasms
- Being tested
- Bevacizumab, Capecitabine, Irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1
CapecitabineDrug
Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4
IrinotecanDrug
Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic CRC | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Capecitabine; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of treatment based on objective response rate
Measured: Every 9 weeks from the start to tumoral progression
Secondary outcomes (3)
Treatment toxicity based on NCI-CTC v4.0
Measured: Every 3 weeks from the start to tumoral progression or toxicity preventing further processing
Progression Free Survival
Measured: Every 9 weeks form the start to tumoral progression
Hepatic metastasis resection rate
Measured: Assessed up 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Ducreux, MD-PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677884
- Sponsor's protocol ID
- 2011-005559-15
- Other IDs
- CSET 2011/1827
- Acronym
- BEVIAC
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2012
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rigault E, Lacas B, Glehen O, Smith D, Dupont-Bierre E, Guimbaud R, Malka D, Boige V, Fuerea A, Pignon JP, Ducreux M. Intra-arterial hepatic bevacizumab and systemic chemotherapy in hepatic metastasis of colorectal cancer: A phase II multicentric trial in second-line treatment. Cancer Treat Res Commun. 2023;34:100674. doi: 10.1016/j.ctarc.2022.100674. Epub 2022 Dec 16.
PubMed 36565566
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy in Hepatic Metastases of Metastatic Colorectal Cancer: a Phase II Multicentric Study With Patients in Progression After First Line Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT01677884
- Acronym / sponsor ID
- BEVIAC / 2011-005559-15
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Sep 2012 (estimated)
- 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.
The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic CRC | Experimental | Drug: Bevacizumab, Drug: Capecitabine, Drug: Irinotecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases)
- Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab
- Age >18 years <75 years
- Performance status WHO 0 or 1
- Life expectancy >3 months
Key exclusion criteria (16 listed)
- Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage, major rectal syndrome)
- Extra-hepatic metastases other than small size disease potentially accessible after resection
- Grade 3-4 allergy to one of the treatment compounds
- Two lines of prior chemotherapy. One line is allowed for metastatic disease but must have been started more than 6 months after completion of adjuvant treatment.
- Participation during or within 30 days before study to another therapeutic trial with an experimental molecule
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 |
|---|---|---|
| BevacizumabEvery 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1 | Drug | Patients with metastatic CRC |
| CapecitabineEvery 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4 | Drug | Patients with metastatic CRC |
| IrinotecanEvery 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line) | Drug | Patients with metastatic CRC |
Primary outcome
Efficiency of treatment based on objective response rate
Time frame: Every 9 weeks from the start to tumoral progression
3 secondary outcomes
Treatment toxicity based on NCI-CTC v4.0
Time frame: Every 3 weeks from the start to tumoral progression or toxicity preventing further processing
Progression Free Survival
Time frame: Every 9 weeks form the start to tumoral progression
Hepatic metastasis resection rate
Time frame: Assessed up 6 months after the end of treatment
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 13 Aug 2026.
- Results publication: PubMed 36565566Rigault E, Lacas B, Glehen O, Smith D, Dupont-Bierre E, Guimbaud R, Malka D, Boige V, Fuerea A, Pignon JP, Ducreux M. Intra-arterial hepatic bevacizumab and systemic chemotherapy in hepatic metastasis of colorectal cancer: A phase II multicentric trial in second-line treatment. Cancer Treat Res Commun. 2023;34:100674. doi: 10.1016/j.ctarc.2022.100674. Epub 2022 Dec 16.
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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.
Michel Ducreux, MD-PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Capecitabine and Irinotecan in people with Colorectal Neoplasms, run by Gustave Roussy, Cancer Campus, Grand Paris 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 14 inclusion and 16 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 13 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficiency of treatment based on objective response rate (time frame: Every 9 weeks from the start to tumoral progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01677884, which also lists 1 linked publication.
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 13 Aug 2026.