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Clinical Trials/EUCTR2018-003048-22-DE
EUCTR2018-003048-22-DE
Active, not recruiting
Phase 1

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 sites56 target enrollmentApril 1, 2019
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Conditionslocally advanced esophageal adenocarcinomaMedDRA version: 20.0Level: LLTClassification code 10001173Term: Adenocarcinoma of esophagusSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsImfinzi®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
locally advanced esophageal adenocarcinoma
Sponsor
niversität zu Köln
Enrollment
56
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 1, 2019
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversität zu Köln

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •\- 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

Outcomes

Primary Outcomes

Not specified

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