PHASE II STUDY OF PREOPERATIVE CHEMORADIOTHERAPY PLUS AVELUMAB IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER - AVANA

G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 个研究点目标入组 101 人开始时间: 2021年6月17日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•Locally advanced, resectable disease defined by the presence of at least one of the following features:
•cN+, cT4, high risk cT3 (according to magnetic resonance imaging [MRI] criteria);
•distal tumor margin at < 12 cm from the anal verge;
•no evidence of metastatic disease by computed tomography (CT) scan of the chest and abdomen and total body FDG-PET/CT scan;
•tumor must be amenable to curative resection;
•no history of invasive rectal malignancy;
•no other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer;
•available tumor samples at baseline (archival biopsy) and after chemoradiotheraphy + avelumab.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 61

•Previous therapy with any antibody or drug targeting T cell coregulatory proteins, or immunosuppressive agents;
•previous pelvic RT;
•active autoimmune disease;
•current use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroids injection (e.g. intra- articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent, steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);
•prior organ transplantation;
•known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
•hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening;
•vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.

发起方

G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST