Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Bevacizumab, capecitabine, oxaliplatin, Pembrolizumab

Tags

MSS/ MMRp

Comments

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.

Location Location Status
France
Ch - Centre Hospitalier D'Abbeville
Abbeville 80090
Not yet recruiting
Chu - Hôpital Sud
Amiens
Recruiting
Privé - Clinique de L'Europe
Amiens
Not yet recruiting
Privé - Ico - Site Paul Papin
Angers 49055
Not yet recruiting
Privé - Hôpital Privé Pays de Savoie
Annemasse 74100
Not yet recruiting
Privé - Hôpital Privé D'Antony
Antony 92160
Recruiting
Ch - Hôpital Henri Duffaut
Avignon 84902
Recruiting
Prive - Institut Du Cancer Avignon Provence
Avignon
Recruiting
Ch - Centre Hospitalier de La Côte Basque
Bayonne CEDEX 64100
Recruiting
Privé - Clinique Capio Balharra
Bayonne
Not yet recruiting
Ch - Centre Hospitalier de Beauvais
Beauvais 60021
Not yet recruiting
Chu - Hôpital Jean Minjoz
Besançon 25030
Not yet recruiting
Privé - Polyclinique Bordeaux Nord
Bordeaux CEDEX 33077
Recruiting
Privé - Cac - Clinique Bergonié
Bordeaux 33076
Recruiting
Privé - Clinique Tivoli
Bordeaux
Recruiting
Ch - Hôpital Duchenne
Boulogne-sur-Mer
Recruiting
Chu - Hôpital Ambroise Paré - Service Anatomie Pathologique
Boulogne
Recruiting
Chu - Hôpital Morvan - Institut de Cancérologie
Brest 29609
Recruiting
Privé - Clinique Pasteur Lanroze Cfro
Brest
Recruiting
Ch - Centre Hospitalier de Béziers
Béziers
Recruiting
Privé - Centre Maurice Tubiana
Caen 14000
Not yet recruiting
Privé - Cac - Centre Francois Baclesse
Caen 14076
Recruiting
Prive - Polyclinique Du Parc Caen
Caen
Not yet recruiting
Privé - Infirmerie Protestante de Lyon
Caluire-et-Cuire 69300
Not yet recruiting
Privé - Médipole de Savoie
Challes-les-Eaux 73190
Not yet recruiting
Privé - Hôpital Privé Paul D'Egine
Champigny-sur-Marne 94500
Recruiting
Ch - Centre Hospitalier de Cholet
Cholet 49300
Recruiting
Chu - Hôpital Estaing
Clermont Ferrand
Recruiting
Ch - Hôpitaux Civils de Colmar
Colmar 68024
Not yet recruiting
Privé - Clinique Saint Come
Compiègne CEDEX 60204
Not yet recruiting
Privé - Clinique de Flandre
Coudekerque-Branche 59210
Recruiting
Ch - Ghpso - Site de Creil
Creil 60100
Not yet recruiting
Chu - Hôpital Henri Mondor
Créteil CEDEX 94000
Recruiting
Ch - Chic de Créteil
Créteil
Not yet recruiting
Chu - Hôpital François Mitterrand
Dijon CEDEX 21079
Recruiting
Privé - Cac - Centre Georges-Francois Leclerc
Dijon 21079
Not yet recruiting
Privé - Polyclinique de Blois - 3Eme Etage
La Chaussee St Victor 41260
Recruiting
Ch - Chd Vendée
La Roche-sur-Yon 85925
Recruiting
CH - GROUPE HOSPITALIER DE La Rochelle RE AUNIS
La Rochelle
Recruiting
Privé - Hôpital Franco Britannique
Levallois-Perret
Recruiting
Privé - Clinique Du Bois
Lille
Not yet recruiting
Chu - Centre Hospitalier Dupuytren
Limoges 87042
Recruiting
Ch - Chbs - Hôpital Du Scorff
Lorient CEDEX 56322
Recruiting
Privé - Hôpital Jean Mermoz
Lyon 69008
Recruiting
Privé - Hôpital Europeen
Marseille CEDEX 03 13331
Recruiting
Chu - Hôpital La Timone
Marseille CEDEX 5 13385
Not yet recruiting
Privé - Hôpital Saint Joseph
Marseille 13008
Recruiting
Privé - Haliodx
Marseille
Recruiting
Ch - Ghi - Groupe Hospitalier de L'Est Francilien - Site de Meaux
Meaux 77100
Recruiting
Ch - Hôpital Layné
Mont-de-Marsan 40 000
Recruiting
Privé - Centre Azureen de Cancerologie
Mougins 06250
Recruiting
Privé - Hôpital Prive Arnault Tzanck
Mougins 06250
Recruiting
Privé - Polyclinique de Gentilly
Nancy 54100
Not yet recruiting
Chu - Hôpital Carémeau
Nîmes 30029
Recruiting
Privé - Institut Mutualiste Montsouris
Paris 75014
Recruiting
Chu - Hôpital Europeen Georges Pompidou
Paris 75015
Recruiting
Privé - Groupe Hospitalier Diaconesses Croix Saint Simon
Paris 75020
Recruiting
Chu - Hôpital Saint Antoine
Paris
Not yet recruiting
Chu - Hôpital Saint-Louis
Paris
Not yet recruiting
Ch - Centre Hospitalier de Pau
Pau CEDEX 64046
Recruiting
Privé - Polyclinique Francheville
Perigueux 24004
Recruiting
Ch - Centre Hospitalier Saint-Jean
Perpignan
Recruiting
Chu - Hôpital Haut Lévêque
Pessac
Not yet recruiting
Chu Lyon Sud - Pierre Benite
Pierre-Bénite 69495
Recruiting
Privé - Centre Cario Hpca
Plérin
Recruiting
Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie
Poitiers 86021
Recruiting
Ch - Chic de Quimper
Quimper
Recruiting
Chu - Centre Hospitalier Universitaire Robert Debre
Reims CEDEX 51092
Recruiting
Privé - Cac - Institut Jean Godinot
Reims 51726
Recruiting
Chu - Centre Hospitalier Universitaire Pontchaillou
Rennes CEDEX 9 35033
Recruiting
Ch - Hôpital Drome Nord
Romans-sur-Isère 26100
Recruiting
Privé - Clinique Saint-Grégoire
Saint-Grégoire
Recruiting
Privé - Cac - Ico - Site René Gauducheau
Saint-Herblain 44805
Not yet recruiting
Ch - Centre Hospitalier de Saint-Malo
Saint-Malo 35403
Recruiting
Chu - Centre Hospitalier Universitaire de Saint Etienne - Hôpital Nord - Service Hge
Saint-Priest-en-Jarez 42270
Recruiting
Privé - Polyclinique Saint-Claude
Saint-Quentin 02100
Not yet recruiting
Privé - Clinique Charcot
Sainte-Foy-lès-Lyon 69510
Not yet recruiting
Privé - Clinique Sainte Anne
Strasbourg 67000
Recruiting
Privé - Cac - Paul Strauss / Institut de Cancérologie de Strasbourg Europe
Strasbourg 67065
Recruiting
Chu - Hôpital Foch
Suresnes 92151
Not yet recruiting
Privé - Polyclinique de L'Ormeau
Tarbes 65000
Not yet recruiting
Ch - Hôpital Sainte Musse
Toulon 83000
Recruiting
Chu - Hôpital Trousseau
Tours CEDEX 9 37044
Recruiting
Ch - Centre Hospitalier de Valenciennes
Valenciennes 59300
Not yet recruiting
Privé - Cac - Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy 54519
Recruiting
Chu - Hôpital Bradois
Vandœuvre-lès-Nancy
Recruiting
Chu - Hôpital Paul Brousse
Villejuif 94804
Not yet recruiting
Privé - Cac - Institut Gustave Roussy
Villejuif
Recruiting

Contacts

Inclusion Criteria

Inclusion Criteria:

Age ≥ 18 years
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

NCT ID

NCT04262687

Date Trial Added

2020-02-10

Updated Date

2023-08-18