A phase II trial to evaluate safety and efficacy of adding durvalumab (MEDI4736) to standard neoadjuvant radiochemotherapy and of adjuvant durvalumab +/- tremelimumab in locally advanced esophageal adenocarcinoma and to evaluate biomarkers predictive for response to immune checkpoint inhibition - RICE: Radio-Immuno-Chemotherapy for Cancer of the Esophagus

niversität zu Köln0 个研究点目标入组 56 人开始时间: 2019年4月1日最近更新: 2020年6月22日

适应症

试验速览

暂无简介。

•written informed consent
•- Histologically confirmed, resectable adenocarcinoma of the esophagus (uT2, uN+, cM0 or uT3, cNx, cM0)
•- No preceding cytotoxic or targeted therapy
•- No prior partial or complete tumour resection
•- Male or female patients = 18 years of age at time of study entry
•- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
•- Study participants must be willing to undergo at least 2 biopsies (baseline, after neoadjuvant treatment)
•- Life expectancy of = 12 months
•- Body weight > 30kg
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 41

•- Study participants with squamous cell carcinoma of the oesophagus
•- Prior treatment with chemotherapy, targeted therapy or radiotherapy for treatment of advanced disease
•- Patients are excluded if they are not resectable because of tumor infiltrating any other organs (cM1), except the stomach, with risk for R1 or R2 resection or if they are not resectable in case of other serious or uncontrolled medical disease.
•- Patients with tumour stadium less than uT3 or confirmed metastatic diseases
•- Any other serious or uncontrolled medical disorder, active infections, physical exam findings, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a study participant’s ability to comply with the study requirements, substantially increase risk to the study participant, or impact the interpretability or study results
•- Presence or history of any other primary malignancy other than adenocarcinoma of the esophagus within 5 years prior to enrolment into the trial, except for adequately treated basal or squamous cell carcinoma of the skin or any adequately treated in situ carcinoma
•- Pregnant or breastfeeding females
•- Patients has known current symptomatic congestive heart failure (NYHA III and IV), unstable angina pectoris, or cardiac arrhythmia

发起方

niversität zu Köln