Adding a Blood-Vessel blocker to maintenance chemo may extend control of advanced colorectal cancer
NCT ID NCT04188145
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding bevacizumab (a drug that starves tumors by blocking new blood vessels) to standard maintenance chemotherapy helps people with metastatic colorectal cancer stay progression-free longer. About 400 adults whose disease is controlled after 4–6 months of initial chemotherapy are randomly assigned to receive either fluoropyrimidine alone or fluoropyrimidine plus bevacizumab. The study measures time to treatment failure, including progression or death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of fluoropyrimidine chemotherapy (capecitabine or 5-FU) and bevacizumab, a drug that blocks blood vessel growth to tumors
- What this could lead to
- If successful, this could establish a more effective maintenance regimen that keeps metastatic colorectal cancer under control longer after initial chemotherapy.
- What could go wrong
- This is a phase 3 trial, but the benefit may be modest, and adding bevacizumab increases risks like bleeding, high blood pressure, and gastrointestinal perforation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed metastatic colorectal adenocarcinoma before induction treatment * Measurable or non-measurable lesion before the induction treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Metastatic, unresectable disease according local practice after induction treatment * ECOG performance status ≤ 2 * Disease control (complete response, partial response or stable disease) after 4-6 months of frontline induction chemotherapy with doublet (fluoropyrimidine + irinotecan or oxaliplatin) or triplet (fluoropyrimidine + irinotecan + oxaliplatin) +/- (cetuximab, panitumumab, bevacizumab) or IAH chemotherapy * Life expectancy \> 3 months * Age ≥ 18 years * Patient is at least 4 weeks from any major surgery * Total bilirubin \< 25 µmol/L, ASAT \< 3 x ULN, ALAT \< 3 x ULN (ASAT , ALAT \< 5 x ULN in case of hepatic metastasis) , PT \>60% , PAL\<2.5 x ULN ( \< 5 x ULN in case of hepatic metastasis) - Neutrophils \> 1500/mm3, platelets \> 100 000/mm3, haemoglobin ≥ 9 g/dL * Creatinin clearance \> 30 ml/min (MDRD) - if creatinin clearance comprised between 30 and 50 ml/min, see smPCs for dose adjustments * Proteinuria ≤ 2+ (dipstick urinalysis) (if more than 2+, so proteinuria at or ≤1g/24hour must be ≤1g) * Patient is able to understand, sign, and date the written informed consent * Evidence of post-menopausal status or negative urinary or serum pregnancy test for premenopausal female patients * Male and female patients of childbearing potential agree to use a highly effective contraceptive measure * Patient affiliated to a social security system Exclusion Criteria: * Myocardial infarction, severe coronaropathy or severe cardiac dysfunction less than 6 months prior randomization * Follow-up impossible * Patients with all metastases resected (R0/R1) after induction chemotherapy * Patient with a hand-foot syndrome \> 1 before maintenance treatment * Known brain or leptomeningeal metastases * Other concomitant or previous malignancy, except: adequately treated in situ carcinoma in complete remission for \> 5 years * Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy * Pregnancy or breast feeding * Treatment with sorivudine or analogs (brivudine) * Treatment with phenytoin or analogs * Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml) * Peptic ulcer not healed after treatment * Any contraindication to bevacizumab or fluoropyrimidine treatments according to the updated SmPC * Intestinal perforation or intestinal fistula * Previous or active gastrointestinal bleeding * Thromboembolic event and/or history of thromboembolic event * Severe hepatic insufficiency
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chu Dijon Bourgogne
Dijon, France
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