Adding a Blood-Vessel blocker to maintenance chemo may extend control of advanced colorectal cancer

NCT ID NCT04188145

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jan 2020

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Chu Dijon Bourgogne

    Dijon, France

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