eoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

Southern Adelaide Local Health Network Inc0 个研究点目标入组 52 人开始时间: 2019年2月26日最近更新: 2021年7月5日

适应症

试验速览

暂无简介。

•1.Male/female patients aged 18 years or older
•2.Histologically confirmed gastro-oesophageal junction or oesophageal adenocarcinoma. Oesophageal and gastroesophageal junction tumours should be TNM7 stage T1-3 and N0-N1, with no evidence of distant metastases (M0) where the MDT believes that an R0 resection can be achieved at the outset. T4 or N2 cancers are excluded as per the CROSS trial eligibility and due to the possible variable need to prolong pre-operative chemotherapy or alternate chemotherapy regimen in CRT to reduce margin involvement and improve resectability.
•3.Absence of distant metastases on CT scan and PET scan and staging laparoscopy (where indicated) prior to study entry.
•4.No prior therapy for oesophageal or GOJ adenocarcinoma

•1.Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of carboplatin or paclitaxel.
•2.Known severe hypersensitivity reactions to monoclonal antibodies (Grade equal to or greater than 3 NCI CTCAE v4.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more features of partially controlled asthma).
•3.Patients who have received immunotherapy for a previous malignancy.
•4.Any previous malignancy, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
•5.Any other histology apart from adenocarcinoma are excluded
•6.Any previous malignancy where patient has had less than or equal to 5 years of a disease free period. If patient has had greater than or equal to 5 years disease free period and where patient is deemed cured, patient may be eligible subject to Chief principle investigator decision.

发起方

Southern Adelaide Local Health Network Inc