Metastatic Colorectal Cancer (CRC)COFRUQNCT07124858
Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
A study testing Fruquintinib in people with Metastatic Colorectal Cancer (CRC) and Antineoplastic Agents, Immunological, run by Federation Francophone de Cancerologie Digestive at 83 sites in France.
Trial summary
The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC), Antineoplastic Agents, Immunological, VEGFR-TKI
- What is being tested?
- Fruquintinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 83 sitesFrance
- Study dates
- 10 Mar 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 18 and over.
- Histologically confirmed colorectal adenocarcinoma with locally advanced disease and/or unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate/early access and ii) marketing authorisation and reimbursement in France.
- Obtain informed consent from the patient for the clinical-biological cohort.
- Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).
Who cannot join
- Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).
- Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).
- Pregnant or breast-feeding women.
- Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).
Trial locations and contacts
83 sites in 1 country. Contact the study team or a site near you to ask about taking part.
83 sites in 1 country
France83 sites, 83 recruiting
- Recruiting
Centre Hospitalier
Albi
CORINNE COUTEAU, 05 61 32 21 42, ccouteau81@gmail.com
- Recruiting
CHU
Amiens
VINCENT HAUTEFEUILLE, 03.22.08.88.54, hautefeuille.vincent@chu-amiens.fr
- Recruiting
Clinique de L Europe
Amiens
FAYCAL HOCINE, 0360125326, faycal.hocine@cthe-amiens.fr
- Recruiting
Centre Hospitalier
Annecy
AUDE MONTCHAUD, +330450636363, amontchaud@ch-annecygenevois.fr
- Recruiting
Centre Hospitalier
Aurillac
DANIELA BURLACU, 04 71 46 47 41, d.burlacu@ch-aurillac.fr
- Recruiting
Centre Hospitalier
Bayeux
ANNIE PEYTIER, 02 31 51 54 17, a.peytier@ch-ab.fr
- Recruiting
Centre Hospitalier
Bayonne
FRANCK AUDEMAR, 0559443722, faudemar@ch-cotebasque.fr
- Recruiting
Centre Hospitalier
Beauvais
HANIFA AMMARGUELLAT, 03 44 11 21 22, h.ammarguellat@ch-beauvais.fr
- Recruiting
CHU
Besançon
ANGELIQUE VIENOT, 0381668393, a3vienot@chu-besancon.fr
- Recruiting
Centre Hospitalier Bethune Beuvry
Beuvry
HELENE VAN DAMME, 03 21 64 43 19, helene.vandamme@ch-bethune.fr
- Recruiting
Centre Pierre Curie
Beuvry
AURELIE FADIN, 03 21 61 92 83, aurelie.fadin@ichf.fr
- Recruiting
Clinique Tivoli
Bordeaux
VALERIE COCHIN, 05 56 69 06 71, v.cochin@tivoli-oncologie.fr
- Recruiting
Polynclinique Bordeaux Nord Aquitaine
Bordeaux
CEDRIC LECAILLE, 0556690681, lecail@hotmail.com
- Recruiting
CHU
Brest
ESTELLE DHAMELINCOURT, 0268223395, estelle.dhamelincourt@chu-brest.fr
- Recruiting
CHU
Caen
KARINE BOUHIER LEPORRIER, 0231064537, bouhierleporrier-k@chu-caen.fr
- Recruiting
Centre Hospitalier
Calais
FATIMA MENIAI, 0321463431, faty_meniai@yahoo.fr
- Recruiting
Infirmerie Protestante
Caluire-et-Cuire
VANDEVOORDE KATIA, 04 72 00 71 96, katia.vandevoorde@infirmerie-protestante.com
- Recruiting
Clinique Sainte Marie
Chalon-sur-Saône
ERIKA VIEL TRUONG, 03 85 48 89 89, viel.erika@orange.fr
- Recruiting
ROC37
Chambray-lès-Tours
PIERRE COMBE, 0247602574, p.combe@cort37.fr
- Recruiting
Centre Hospitalier
Chartres
CHLOE GENET, 02 37 30 30 77, cgenet@ch-chartres.fr
- Recruiting
Centre Hospitalier
Cholet
VICTOR SIMMET, 02 41 35 68 12, victor.simmet@ch-cholet.fr
- Recruiting
Clinique Sainte Come
Compiègne
KAIS ALDABBAGH, 03 44 92 43 53, kais.aldabbagh@stcome.com
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
SAMY LOUAFI, 0161693077, samy.louafi@gmail.com
- Recruiting
Clinique Branche - Clinique Flandres
Coudekerque-Branche
JEAN BAPTISTE AISENFARB, 0328281439, jbaisenfarb@iadonco.org
- Recruiting
Centre Hospitalier Henri Mondor
Créteil
CHARLOTTE FENIOUX, 06 95 41 28 87, charlotte.fenioux@aphp.fr
- Recruiting
Centre Leonard de Vinci
Dechy
CLAIRE GIRAUD, 03 27 08 60 63, cgiraud@clinique-psv.fr
- Recruiting
Chu Francois Mitterand
Dijon
SYLVAIN MANFREDI, 0380293750, sylvain.manfredi@chu-dijon.fr
- Recruiting
Institut de Cancerologie de Bourgogne
Dijon
ARIANE DARUT-JOUVE, 03 80 67 30 10, adarut-jouve@icb-cancer.fr
- Recruiting
Hopital Prive Forcilles
Férolles-Attilly
ABDELKRIM HARRACH, 0786851366, karimoncologie@yahoo.fr
- Recruiting
Centre Hospitalier
Flers
PIERRE EMMANUEL HENNERESSE, 02 33 62 62 28, pierre-emmanuel.henneresse@ght-cdn.fr
- Recruiting
CHI
Fréjus
MAYA AL GHOR, 0494558783, maya.alghor@chi-fsr.fr
- Recruiting
Groupe Hospitalier Mutualiste
Grenoble
HELENE FLESCH, 04 76 70 73 33, helene.flesch@avec.fr
- Recruiting
Polyclinique de Blois
La Chaussée-Saint-Victor
PHILIPPE LAPLAIGE, 02 54 90 65 55, dr.laplaige@wanadoo.fr
- Recruiting
Clinique Sainte Clothilde
La Réunion
FREDDY RANDRIANASOLO, +330262482040, freddy.randrianasolo@clinifutur.net
- Recruiting
Centre Hospitalier de Vendee
La Roche-sur-Yon
MARGOT LALY, 02 51 44 61 68, margot.laly@ght85.fr
- Recruiting
Hopital Prive de L Estuaire
Le Havre
HELEN HOMOKOS, 02 76 89 97 84, h.homokos@ramsaygds.fr
- Recruiting
Centre Hospitalier
Le Puy-en-Velay
KHEIR-EDDINE BENMAMMAR, 04 71 04 33 36, medical133@yahoo.fr
- Recruiting
Centre Hospitalier
Lens
FABIENNE WATELLE, 03 21 69 16 74, fwatelle@ch-lens.fr
- Recruiting
CHU
Lille
ANNE PLOQUIN, 03 20 44 54 61, anne.ploquin@chru-lille.fr
- Recruiting
CHU
Limoges
FREDERIC THUILLIER, 0555056396, frederic.thuillier@chu-limoges.fr
- Recruiting
Groupement Hospitalier Bretagne Sud
Lorient
EDWINA GIRARD, 0297069695, e.girard@ghbs.bzh
- Recruiting
Clinique Jean Mermoz
Lyon
PASCAL ARTRU, 04.37.53.87.26, dr.artru@wanadoo.fr
- Recruiting
Hopital Europeen
Marseille
NICOLAS BARRIERE, 04 13 42 77 13, n.barriere@hopital-europeen.fr
- Recruiting
Hopital Saint Joseph
Marseille
HERVE PERRIER, 04 91 80 82 11, hperrier@hopital-saint-joseph.fr
- Recruiting
La Timone
Marseille
LAETITIA DAHAN, 0491386023, laetitia.dahan@ap-hm.fr
- Recruiting
Clinique Gray
Maubeuge
LAURENT GILBEAU, 03 27 69 83 83, gilbeaulaurent@gmail.com
- Recruiting
Ch Du Mittan
Montbéliard
THIERRY NGUYEN TAN HON, 03 81 66 87 05, doctnguyen@hotmail.com
- Recruiting
Institut de Cancerologie de Lorraine
Nancy
MARIE CHRISTINE KAMINSKY, 03 83 59 84 61, mc.kaminsky@nancy.unicancer.fr
- Recruiting
Hopital Prive Confluent
Nantes
HELENE CASTANIE, 02 28 27 21 61, helene.castanie@groupeconfluent.fr
- Recruiting
Clinique Ambroise Pare Hartmann
Neuilly
JEAN MICHEL VANNETZEL, 01 47 59 00 00, dr.vannetzel@gmail.com
- Recruiting
Hopital Americain
Neuilly-sur-Seine
LIONEL VEDRINE, 01 46 41 82 46, lionelvedrine@orange.fr
- Recruiting
Centre Hospitalier
Niort
AUDREY PERRET, 05.49.78.24.82, audrey.perret@ch-niort.fr
- Recruiting
CH de la source
Orléans
Barbara DAUVOIS, 02 38 51 47 04, barbara.dauvois@chr-orleans.fr
- Recruiting
BICHAT
Paris
GAEL GOUJON, 01 40 25 87 16, gael.goujon@aphp.fr
- Recruiting
COCHIN
Paris
ROMAIN CORIAT, 01 58 41 19 52, romain.coriat@aphp.fr
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
OLIVIER DUBREUIL, 0144742839, odubreuil@hopital-dcss.org
- Recruiting
Hopital Avicenne
Paris
FLORENCE MARY, 01 48 95 54 34, florence.mary@aphp.fr
- Recruiting
Hopital Saint Louis
Paris
THOMAS APARICIO, 01 42 49 95 97, thomas.aparicio@aphp.fr
- Recruiting
La Pitie Salepetriere
Paris
JEAN BAPTISTE BACHET, 0142161041, jean-baptiste.bachet@aphp.fr
- Recruiting
Saint Antoine
Paris
ROMAIN COHEN, 01 49 28 23 36, romain.cohen@aphp.fr
- Recruiting
Centre Hospitalier
Pau
JULIETTE THAURY, 05 59 92 49 83, juliette.thaury@ch-pau.fr
- Recruiting
Hopital Instruction Des Armees
Percy
CHLOE MATRAY, +330141466616, chloe.matray@intradef.gouv.fr
- Recruiting
Centre Hospitalier
Perpignan
FAIZA KHEMISSA, 0468616137, faiza.khemissa@ch-perpignan.fr
- Recruiting
CHU
Pessac
DENIS SMITH, 05 57 65 64 39, denis.smith@chu-bordeaux.fr
- Recruiting
Lyon Sud
Pierre-Bénite
MARION CHAUVENET, 0478861302, marion.chauvenet@chu-lyon.fr
- Recruiting
Centre Cario
Plérin
JEROME MARTIN-BABAU, 0296752216, j.martin@cario-sante.fr
- Recruiting
Poitiers CHU
Poitiers, France, 86021
David Pr TOUGERON, DIGESTIV ONCOLOGIST, +33 0549443751, david.tougeron@chu-poitiers.fr
- Recruiting
CHU
Poitiers
DAVID TOUGERON, 0549443751, david.tougeron@chu-poitiers.fr
- Recruiting
CHU
Reims
OLIVIER BOUCHE, 03 26 78 31 13, obouche@chu-reims.fr
- Recruiting
CHU
Rennes
ASTRID LIEVRE, 0299284347, astrid.lievre@chu-rennes.fr
- Recruiting
CHU
Rouen
ADRIEN GRANCHER, 0232886293, adrien.grancher@chu-rouen.fr
- Recruiting
Centre Hospitalier
Saint-Denis
GAETAN DES GUETZ, 0142356140, gaetan.desguetz@ch-stdenis.fr
- Recruiting
Centre Hospitalier
Soissons
SARAH MONTEMBAULT, 03 26 96 68 59, sarah.montembault@ch-soissons.fr
- Recruiting
Centre Hospitalier
St-Malo
JULIETTE VIAUD, 02 99 21 21 50, j.viaud@ch-stmalo.fr
- Recruiting
Clinique Sainte Anne
Strasbourg
LOUIS MARIE DOURTHE, 0388453750, lm.dourthe@solcrr.org
- Recruiting
Centre Hospitalier
Thonon-les-Bains
FANNY POMMERET, 04 50 83 21 25, f-pommeret@ch-hopitauxduleman.fr
- Recruiting
Chu Rangueil
Toulouse
MARION DESLANDRES, 05 61 32 21 76, deslandres.m@chu-toulouse.fr
- Recruiting
CHU
Tours
THIERRY LECOMTE, 02 47 47 59 00, thierry.lecomte@univ-tours.fr
- Recruiting
Hopital Prive Drome Ardeche
Valence
AGNES PELAQUIER, 04 75 53 40 58, agnes.pelaquier@orange.fr
- Recruiting
CHU
Vandœuvre-lès-Nancy
MARIE MULLER, 0383155179, m.muller7@chru-nancy.fr
- Recruiting
Centre Hospitalier
Versailles
ANTONIN VARY, +330139637714, avary@ght78sud.fr
- Recruiting
Hopital Nord Ouest
Villefranche-sur-Saône
JONATHAN OLESINSKI, 06 77 40 90 73, jolesinski@hno.fr
- Recruiting
Medipole Hopital Mutualiste
Villeurbanne
MATTHIEU SARABI, 04 37 53 87 26, m.sarabi@gelmad.fr
About this study
Official title: PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.
Read the detailed description
Fruquintinib (a novel, highly selective oral tyrosine kinase inhibitor targeting VEGFR-1, -2, and -3) has demonstrated efficacy in chemotherapy-resistant metastatic colorectal cancer (mCRC) in two phase III trials, FRESCO and FRESCO-2. In France, fruquintinib has been available through compassionate use since January 16, 2024, for all patients with chemotherapy-refractory mCRC, and its reimbursement is expected in the coming months. However, limited real-world data are currently available regarding the use of this new treatment and the identification of predictive factors of its efficacy, both clinically and biologically.
Moreover, there is a significant lack of information concerning older patients (≥70 years), who are often underrepresented in registration trials. This cohort will therefore provide a unique opportunity to gather specific data in elderly patients, including the integration of geriatric assessment parameters.
The main objectives of this cohort will be to validate, in routine clinical practice, the survival and safety outcomes observed in the FRESCO-2 trial, and to identify clinical and biological prognostic and predictive factors of survival in patients treated with fruquintinib.
As such, the COFRUQ cohort could help identify patients who derive the greatest survival benefit from fruquintinib and thereby contribute to optimizing their therapeutic pathway.
- Being tested
- Fruquintinib
- Keywords
- Metastatic colorectal cancer, Fruquintinib, cohort
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Fruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib | Other | Fruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal. Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
OS is defined as the time interval (months) between the date of initiation of treatment with fruquintinib and the date of death (from any cause).
Measured: up to 1 year after treatment start
Secondary outcomes (1)
progression free survival
Time (months) from initiation of treatment with fruquintinib to radiological and/or clinical tumour progression or death from any cause.
Measured: up to 1 year after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start10 Mar 2026
- Primary completion1 Mar 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124858
- Sponsor's protocol ID
- COFRUQ COHORT
- Other IDs
- 2024-A00994-43
- Acronym
- COFRUQ
- Status last verified
- May 2026
- First submitted
- 8 Aug 2025
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07124858
- Acronym / sponsor ID
- COFRUQ / COFRUQ COHORT
- Keywords
- Metastatic colorectal cancer, Fruquintinib, cohort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 15 Aug 2025 (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.
The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.
Detailed description
Fruquintinib (a novel, highly selective oral tyrosine kinase inhibitor targeting VEGFR-1, -2, and -3) has demonstrated efficacy in chemotherapy-resistant metastatic colorectal cancer (mCRC) in two phase III trials, FRESCO and FRESCO-2. In France, fruquintinib has been available through compassionate use since January 16, 2024, for all patients with chemotherapy-refractory mCRC, and its reimbursement is expected in the coming months. However, limited real-world data are currently available regarding the use of this new treatment and the identification of predictive factors of its efficacy, both clinically and biologically.
Moreover, there is a significant lack of information concerning older patients (≥70 years), who are often underrepresented in registration trials. This cohort will therefore provide a unique opportunity to gather specific data in elderly patients, including the integration of geriatric assessment parameters.
The main objectives of this cohort will be to validate, in routine clinical practice, the survival and safety outcomes observed in the FRESCO-2 trial, and to identify clinical and biological prognostic and predictive factors of survival in patients treated with fruquintinib.
As such, the COFRUQ cohort could help identify patients who derive the greatest survival benefit from fruquintinib and thereby contribute to optimizing their therapeutic pathway.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib | Other | Drug: FruquintinibFruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 and over.
- Histologically confirmed colorectal adenocarcinoma with locally advanced disease and/or unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate/early access and ii) marketing authorisation and reimbursement in France.
- Obtain informed consent from the patient for the clinical-biological cohort.
- Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).
Key exclusion criteria (4 listed)
- Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).
- Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).
- Pregnant or breast-feeding women.
- Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).
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 |
|---|---|---|
| FruquintinibFruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal. | Drug | Fruquintinib |
Primary outcome
overall survival
Time frame: up to 1 year after treatment start
OS is defined as the time interval (months) between the date of initiation of treatment with fruquintinib and the date of death (from any cause).
1 secondary outcome
progression free survival
Time frame: up to 1 year after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
83 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruquintinib in people with Metastatic Colorectal Cancer (CRC) and Antineoplastic Agents, Immunological, run by Federation Francophone de Cancerologie Digestive at 83 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: up to 1 year after treatment start). 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 26 May 2026.