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

计划状态

招聘

阶段

第二阶段

允许先接受免疫治疗

没有

CRC 指导的试验

是

药物

Bevacizumab, capecitabine, oxaliplatin, Pembrolizumab

标签

MSS/ MMRp

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.

有用链接

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

地点	位置状态
法国
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Ch - Hôpital Henri Duffaut Avignon 84902	招聘
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Ch - Hôpital Duchenne Boulogne-sur-Mer	招聘
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Ch - Hôpital Layné Mont-de-Marsan 40 000	招聘
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Ch - Centre Hospitalier de Pau Pau CEDEX 64046	招聘
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Chu Lyon Sud - Pierre Benite Pierre-Bénite 69495	招聘
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Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie Poitiers 86021	招聘
Ch - Chic de Quimper Quimper	招聘
Chu - Centre Hospitalier Universitaire Robert Debre Reims CEDEX 51092	招聘
Privé - Cac - Institut Jean Godinot Reims 51726	招聘
Chu - Centre Hospitalier Universitaire Pontchaillou Rennes CEDEX 9 35033	招聘
Ch - Hôpital Drome Nord Romans-sur-Isère 26100	招聘
Privé - Clinique Saint-Grégoire Saint-Grégoire	招聘
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Ch - Centre Hospitalier de Saint-Malo Saint-Malo 35403	招聘
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Chu - Hôpital Foch Suresnes 92151	尚未招聘
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Privé - Cac - Institut Gustave Roussy Villejuif	招聘

联系方式

Jeremie BEZ
联系方式
0380393483 jeremie.bez@u-bourgogne.fr

纳入标准

年龄 ≥ 18 岁
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

添加审判日期

2020-02-10

更新日期

2023-08-18