Estado del programa
ReclutamientoFase
Fase 2Inmunoterapia previa permitida
NoEnsayo dirigido por el CRC
SíDrogas
Bevacizumab, capecitabine, oxaliplatin, PembrolizumabEtiquetas
MSS/ MMRpComentarios
POCHI trial: for MSS CRC patients with a high immune response.
“Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes” ” it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC”.
Immunotherapy + chemotherapy: Xelox bevacizumab plus pembrolizumab
Prior immunotherapy no allowed.
Enlaces útiles
Pembrolizumab in combination with CAPOX and bevacizumab in patients with microsatellite stable metastatic colorectal cancer and a high immune infiltrate: Preliminary results of FFCD 1703 POCHI trial https://www.onclive.com/view/pembrolizumab-plus-bevacizumab-capox-yields-responses-in-pmmr-mss-mcrc-with-high-tils Pembrolizumab combined with xelox and bevacizumab shows higher efficacy than standard therapeutic regimen in mCRC| Ubicación | Situación |
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| Francia | |
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Ch - Centre Hospitalier D'Abbeville Abbeville 80090 |
Aún no se ha contratado |
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Chu - Hôpital Sud Amiens |
Reclutamiento |
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Privé - Clinique de L'Europe Amiens |
Aún no se ha contratado |
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Privé - Ico - Site Paul Papin Angers 49055 |
Aún no se ha contratado |
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Privé - Hôpital Privé Pays de Savoie Annemasse 74100 |
Aún no se ha contratado |
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Privé - Hôpital Privé D'Antony Antony 92160 |
Reclutamiento |
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Ch - Hôpital Henri Duffaut Avignon 84902 |
Reclutamiento |
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Prive - Institut Du Cancer Avignon Provence Avignon |
Reclutamiento |
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Ch - Centre Hospitalier de La Côte Basque Bayonne CEDEX 64100 |
Reclutamiento |
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Privé - Clinique Capio Balharra Bayonne |
Aún no se ha contratado |
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Ch - Centre Hospitalier de Beauvais Beauvais 60021 |
Aún no se ha contratado |
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Chu - Hôpital Jean Minjoz Besançon 25030 |
Aún no se ha contratado |
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Privé - Polyclinique Bordeaux Nord Bordeaux CEDEX 33077 |
Reclutamiento |
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Privé - Cac - Clinique Bergonié Burdeos 33076 |
Reclutamiento |
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Privé - Clinique Tivoli Bordeaux |
Reclutamiento |
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Ch - Hôpital Duchenne Boulogne-sur-Mer |
Reclutamiento |
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Chu - Hôpital Ambroise Paré - Service Anatomie Pathologique Boulogne |
Reclutamiento |
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Chu - Hôpital Morvan - Institut de Cancérologie Brest 29609 |
Reclutamiento |
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Privé - Clinique Pasteur Lanroze Cfro Brest |
Reclutamiento |
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Ch - Centre Hospitalier de Béziers Béziers |
Reclutamiento |
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Privé - Centre Maurice Tubiana Caen 14000 |
Aún no se ha contratado |
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Privé - Cac - Centre Francois Baclesse Caen 14076 |
Reclutamiento |
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Prive - Polyclinique Du Parc Caen Caen |
Aún no se ha contratado |
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Privé - Infirmerie Protestante de Lyon Caluire-et-Cuire 69300 |
Aún no se ha contratado |
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Privé - Médipole de Savoie Challes-les-Eaux 73190 |
Aún no se ha contratado |
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Privé - Hôpital Privé Paul D'Egine Champigny-sur-Marne 94500 |
Reclutamiento |
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Ch - Centre Hospitalier de Cholet Cholet 49300 |
Reclutamiento |
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Chu - Hôpital Estaing Clermont Ferrand |
Reclutamiento |
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Ch - Hôpitaux Civils de Colmar Colmar 68024 |
Aún no se ha contratado |
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Privé - Clinique Saint Come Compiègne CEDEX 60204 |
Aún no se ha contratado |
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Privé - Clinique de Flandre Coudekerque-Branche 59210 |
Reclutamiento |
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Ch - Ghpso - Site de Creil Creil 60100 |
Aún no se ha contratado |
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Chu - Hôpital Henri Mondor Créteil CEDEX 94000 |
Reclutamiento |
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Ch - Chic de Créteil Créteil |
Aún no se ha contratado |
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Chu - Hôpital François Mitterrand Dijon CEDEX 21079 |
Reclutamiento |
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Privé - Cac - Centre Georges-Francois Leclerc Dijon 21079 |
Aún no se ha contratado |
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Privé - Polyclinique de Blois - 3Eme Etage La Chaussee St Victor 41260 |
Reclutamiento |
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Ch - Chd Vendée La Roche-sur-Yon 85925 |
Reclutamiento |
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CH - GROUPE HOSPITALIER DE La Rochelle RE AUNIS La Rochelle |
Reclutamiento |
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Privé - Hôpital Franco Britannique Levallois-Perret |
Reclutamiento |
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Privé - Clinique Du Bois Lille |
Aún no se ha contratado |
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Chu - Centre Hospitalier Dupuytren Limoges 87042 |
Reclutamiento |
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Ch - Chbs - Hôpital Du Scorff Lorient CEDEX 56322 |
Reclutamiento |
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Privé - Hôpital Jean Mermoz Lyon 69008 |
Reclutamiento |
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Privé - Hôpital Europeen Marseille CEDEX 03 13331 |
Reclutamiento |
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Chu - Hôpital La Timone Marseille CEDEX 5 13385 |
Aún no se ha contratado |
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Privé - Hôpital Saint Joseph Marseille 13008 |
Reclutamiento |
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Privé - Haliodx Marseille |
Reclutamiento |
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Ch - Ghi - Groupe Hospitalier de L'Est Francilien - Site de Meaux Meaux 77100 |
Reclutamiento |
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Ch - Hôpital Layné Mont-de-Marsan 40 000 |
Reclutamiento |
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Privé - Centre Azureen de Cancerologie Mougins 06250 |
Reclutamiento |
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Privé - Hôpital Prive Arnault Tzanck Mougins 06250 |
Reclutamiento |
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Privé - Polyclinique de Gentilly Nancy 54100 |
Aún no se ha contratado |
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Chu - Hôpital Carémeau Nîmes 30029 |
Reclutamiento |
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Privé - Institut Mutualiste Montsouris Paris 75014 |
Reclutamiento |
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Chu - Hôpital Europeen Georges Pompidou París 75015 |
Reclutamiento |
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Privé - Groupe Hospitalier Diaconesses Croix Saint Simon Paris 75020 |
Reclutamiento |
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Chu - Hôpital Saint Antoine Paris |
Aún no se ha contratado |
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Chu - Hôpital Saint-Louis Paris |
Aún no se ha contratado |
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Ch - Centre Hospitalier de Pau Pau CEDEX 64046 |
Reclutamiento |
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Privé - Polyclinique Francheville Perigueux 24004 |
Reclutamiento |
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Ch - Centre Hospitalier Saint-Jean Perpignan |
Reclutamiento |
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Chu - Hôpital Haut Lévêque Pessac |
Aún no se ha contratado |
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Chu Lyon Sud - Pierre Benite Pierre-Bénite 69495 |
Reclutamiento |
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Privé - Centre Cario Hpca Plérin |
Reclutamiento |
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Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie Poitiers 86021 |
Reclutamiento |
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Ch - Chic de Quimper Quimper |
Reclutamiento |
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Chu - Centre Hospitalier Universitaire Robert Debre Reims CEDEX 51092 |
Reclutamiento |
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Privé - Cac - Institut Jean Godinot Reims 51726 |
Reclutamiento |
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Chu - Centre Hospitalier Universitaire Pontchaillou Rennes CEDEX 9 35033 |
Reclutamiento |
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Ch - Hôpital Drome Nord Romans-sur-Isère 26100 |
Reclutamiento |
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Privé - Clinique Saint-Grégoire Saint-Grégoire |
Reclutamiento |
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Privé - Cac - Ico - Site René Gauducheau Saint-Herblain 44805 |
Aún no se ha contratado |
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Ch - Centre Hospitalier de Saint-Malo Saint-Malo 35403 |
Reclutamiento |
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Chu - Centre Hospitalier Universitaire de Saint Etienne - Hôpital Nord - Service Hge Saint-Priest-en-Jarez 42270 |
Reclutamiento |
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Privé - Polyclinique Saint-Claude Saint-Quentin 02100 |
Aún no se ha contratado |
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Privé - Clinique Charcot Sainte-Foy-lès-Lyon 69510 |
Aún no se ha contratado |
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Privé - Clinique Sainte Anne Strasbourg 67000 |
Reclutamiento |
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Privé - Cac - Paul Strauss / Institut de Cancérologie de Strasbourg Europe Strasbourg 67065 |
Reclutamiento |
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Chu - Hôpital Foch Suresnes 92151 |
Aún no se ha contratado |
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Privé - Polyclinique de L'Ormeau Tarbes 65000 |
Aún no se ha contratado |
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Ch - Hôpital Sainte Musse Toulon 83000 |
Reclutamiento |
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Chu - Hôpital Trousseau Tours CEDEX 9 37044 |
Reclutamiento |
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Ch - Centre Hospitalier de Valenciennes Valenciennes 59300 |
Aún no se ha contratado |
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Privé - Cac - Institut de Cancerologie de Lorraine Vandœuvre-lès-Nancy 54519 |
Reclutamiento |
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Chu - Hôpital Bradois Vandœuvre-lès-Nancy |
Reclutamiento |
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Chu - Hôpital Paul Brousse Villejuif 94804 |
Aún no se ha contratado |
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Privé - Cac - Institut Gustave Roussy Villejuif |
Reclutamiento |
Contactos
Criterios de inclusión
Criterios de inclusión:
Edad ≥ 18 años
MSS and pMMR metastatic colorectal adenocarcinoma (metachronous or synchronous metastases), histologically proven
Patients who have had chemotherapy (neo-adjuvant or adjuvant) or radiotherapy (neo-adjuvant or adjuvant) for the treatment of primary tumor or metastatic resected disease R0 can be included if they have a recurrence more than 6 months after the end of this treatment.
High immune response defined as the immune infiltration scores obtained on the primary tumour (resection of primary tumour containing at least 2 mm of tumour-free margin between the tumour and non-tumour area)
Unresectable cancer with at least one measurable metastatic target according to RECIST v1.1 criteria
WHO PS ≤ 1
Life expectancy ≥ 3 months
Adequate haematological function: neutrophils ≥ 1,500 /mm3, platelets ≥ 100,000/mm3, Hb > 9 g/dL
Adequate liver function: AST/ALT ≤ 5xULN, total bilirubin ≤ 2xULN, alkaline phosphatase. ≤ 5xULN
Creatinine clearance > 50 mL/min according to the MDRD formula
Proteinuria 450 msec in men and > 470 msec in women
One of the following disorders during the 6 months prior to inclusion: myocardial infarction, unstable/severe angina pectoris, coronary artery bypass grafting, NYHA class II, III or IV congestive heart failure, stroke or transient ischaemic attack
All uncontrolled progressive disorders during the last 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency, arterial hypertension
History of an inflammatory digestive disease, obstruction or sub-obstruction not resolved with symptomatic treatment
Peptic ulcer disease not healed before the treatment
Not controlled HTA
Patient already enrolled in another therapeutic trial with an ongoing investigational drug or whose treatment ended less than 4 weeks before inclusion
Absence of effective contraception in patients (male and/or female patients) of childbearing potential, a pregnant or breastfeeding woman, women of childbearing potential and who have not had a pregnancy test
Impossibility to submit to medical follow-up of the trial due to geographic, social or psychological reasons
