Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo aims to improve colorectal cancer treatment

NCT ID NCT07150403

Disease control Sponsor: Federation Francophone de Cancerologie Digestive Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tests whether a new drug called fruquintinib, combined with standard chemotherapy, can control advanced colorectal cancer better than the current standard treatment (bevacizumab plus chemotherapy). About 74 adults whose cancer has worsened after first-line therapy will be randomly assigned to one of the two combinations. The main goal is to see how many patients have their disease controlled at 4 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fruquintinib
What this could lead to
If successful, this could provide a new second-line treatment option for people with metastatic colorectal cancer.
What could go wrong
This is an early phase 2 trial with only 74 participants, so results may not apply to everyone. The drug may not work better than the current standard or could have unexpected side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Oct 2028

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 to 80 years

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: * \- Age ≥ 18 years and ≤ 80 years; provided the score of the G8 geriatric questionnaire is \>14 for patients 75 years or older * Patients with a histologically confirmed diagnosis of metastatic colorectal cancer (mCRC), with a documented disease progression (as per RECIST v1.1, assessed by the investigator and confirmed through CT or MRI). * Patients must have previously received first-line therapy with Bevacizumab or an EGFRi, in combination with either FOLFOX or FOLFIRI, for non-resectable mCRC. Patients who progressed during the adjuvant chemotherapy (FOLFOX) or within the 6 months following its completion are eligible for inclusion * Patients must have an unresectable tumor at the time of enrollment. * Patients must have at least one measurable/evaluable metastatic lesion according to RECIST v1.1 criteria; images have to be available for collection * Metastases not amenable to surgery and/or thermo-ablation and/or stereotaxic radiotherapy * WHO performance status 0 or 1 * Available parameters to compute the SPOD score: WHO PS, hemoglobin, platelet count, WBC/absolute neutrophil count ratio, lactate dehydrogenase (LDH), alkaline phosphatase, and the number of metastatic sites. * Adequate liver functions: Total Bilirubinemia \< 2,5 ULN, AST and ALT ≤ 5 ULN * Adequate hematological (Hemoglobin ≥10g/dL, platelets ≥100G/L, neutrophils ≥1.5G/L) and renal (creatinine clearance ≥ 50 mL/min according to CKD-EPI) functions * Proteinuria \< 2+ (dipstick urinalysis) (if 2+ or more, proteinuria must be ≤1g/24hour) * Life expectancy ≥ 3 months * Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relations with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments * Ability of the patient to understand, sign and date the information note and informed consent form before any study specific procedures * Patient affiliated to a social security scheme * Available tumor sample and pathology report for collection Exclusion Criteria: * \- Patients who have received more than one prior systemic therapy * FOLFIRINOX Regimen +/- targeted therapy in the first line setting * Unknown RAS status * BRAF V600E mutated tumor * MSI/dMMR tumor * Known brain metastasis * Known peritoneal carcinomatosis if there are signs of clinical occlusion or sub-occlusion * History of gastric ulceration, or myocardial infarction, or severe coronaropathy or severe cardiac dysfunction, within the past 6 months prior to treatment start * Patients with dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL) * Hypersensitivity to one of the study drugs or one of its excipients * Inability to swallow capsules * Live attenuated vaccines 30 days prior to treatment start * Untreated bone fracture * Significant haemorrhagic diathesis or coagulopathy (in the absence of anti-coagulant treatment) * Major surgery, open biopsy or major traumatic lesion in the prior 30 days or the need for major surgery during the trial * Pregnant or breastfeeding woman or patients with no adequate contraception * Known Uridine Diphosphate Glucuronyltransferase (UGT1A1) deficiency or known Gilbert disease * Strong inducers of CYP3A4 (treatment with St John's Wort (Hypericum perforatum), fampicin, phenobarbital, primidone, phenytoin and carbamazepine) \-- Strong inhibitors of CYP3A4, continuous use of azole antifungals (posaconazole, voriconazole, itraconazole, isavuconazole), ritonavir, verapamil, diltiazem, grapefruit juice (equivalent to half a fresh grapefruit/day) * Concomitant or recent treatment with sorivudine or its analogs (including brivudine) within 4 weeks prior to the administration of protocol treatment (related to Fluorouracil) * Concomitant treatment with phenytoin or its analogs * QT/QTc interval \> 450 ms for men and \> 470 ms for women * Uncontrolled hypertension (defined as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg) or history of hypertensive crisis (TA systolic\> 20 mmHg) or hypertensive encephalopathy * History of veinous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within the past month prior to study enrollment * History of stroke and/or transient ischemic attack (TIA) within the past 12 months * Residual Oxaliplatin neuropathy (grade ≥ 2) counter indicates FOLFOX administration * Persistence of clinically significant symptoms after a thromboembolic event despite anticoagulant treatment * Arterial thromboembolism (myocardial infarction, stroke, transient ischemic attack) occurring under antiangiogenic therapy * Other active cancers or history of cancer treated within the last 5 years except for carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured * Persons deprived of liberty or under guardianship or unable of giving consent * Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic colorectal carcinoma (MCRC) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal carcinoma (MCRC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BERGONIÉ

    Bordeaux, France

  • BRABOIS

    Vandœuvre-lès-Nancy, France

  • Bayeux Ch

    Bayeux, France

  • Beauvais Ch

    Beauvais, France

  • CHD Vendée

    La Roche-sur-Yon, France

  • Centre Leonard de Vinci

    Dechy, France

  • Centre Pierre Curie

    Beuvry, France

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, France

  • Ch Nord Ouest

    Villefranche-sur-Saône, France

  • Chauny Ch

    Chauny, France

  • Cholet Ch

    Cholet, France

  • Clinique Mutualiste de L'Estuaire

    Saint-Nazaire, France

  • Clinique de Flandre

    Coudekerque-Branche, France

  • Confluent Sas

    Nantes, France

  • Cote Basque

    Bayonne, France

  • Dijon Bourgogne

    Dijon, France

  • Docteur Schaffner

    Lens, France

  • Franco Britannique

    Levallois-Perret, France

  • GHPSO Site de Creil

    Creil, France

  • Ght Unyon Auxerre

    Auxerre, France

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, France

  • Gustave Roussy

    Villejuif, France

  • Hopital Nord Chu Saint Etienne

    Saint-Priest-en-Jarez, France

  • Hôpital Européen G Pompidou

    Paris, France

  • ICAN Institut de Cancérologie de Strasbourg Europe

    Strasbourg, France

  • ICO Site Paul Papin

    Angers, France

  • ICO Site René Gauducheau

    Saint-Herblain, France

  • Institut de cancérologie de Bourgogne GRReCC

    Dijon, France

  • Jean Godinot

    Reims, France

  • Jean Mermoz

    Lyon, France

  • Jean Minjoz

    Besançon, France

  • LAYNÉ CH

    Mont-de-Marsan, France

  • LEMAN

    Thonon-les-Bains, France

  • La Miletrie

    Poitiers, France

  • La Pitié Salpêtrière

    Paris, France

  • La Timone

    Marseille, France

  • Les Bonnettes

    Arras, France

  • Robert Debré

    Reims, France

  • Saint Côme

    Compiègne, France

  • Saint Gregoire Chp

    Saint-Grégoire, France

  • Saint Louis

    Paris, France

  • Saint Malo Ch

    St-Malo, France

  • Sainte Anne

    Strasbourg, France

  • TIVOLI

    Bordeaux, France

  • Valence Ch

    Valence, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.