Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05713838

Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery

Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2024-09-19

32

Participants Needed

22

Research Sites

274 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial investigating whether a definite organ preservation therapy consisting of the combination of durvalumab with chemoradiation is an efficient and safe treatment option for early stage, cT1 and cT2N0, esophageal adenocarcinoma with indication for radical surgery.

CONDITIONS

Official Title

Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has given written informed consent.
  • Patient is willing and able to comply with the study protocol including planned surgery.
  • Patient is 18 years of age or older.
  • Histologically confirmed esophageal adenocarcinoma (including gastroesophageal junction Siewert I-III) with cT1 N0 M0 or cT2 N0 M0 stage and indication for radical surgical resection.
  • Tumor is medically and technically resectable.
  • Tumor tested locally for PD-L1 combined positive score (CPS) with results available before enrollment.
  • Patient has not received prior cytotoxic or targeted therapy.
  • Patient has not had prior complete esophagogastric tumor resection.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Female patients of childbearing potential and male patients with female partners agree to use effective contraception or abstain during and after treatment as specified.
  • Body weight greater than 30 kg.
  • Adequate blood counts, liver and kidney function as specified.
  • No HIV infection or stable HIV infection meeting specific criteria.
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to durvalumab components or history of severe allergic reactions to similar antibodies.
  • Contraindications or hypersensitivity to docetaxel, 5-FU, leucovorin, or oxaliplatin.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency (except reduced activity with dose adjustment).
  • Active or history of autoimmune disease except controlled thyroid or diabetes as defined.
  • Prior allogeneic bone marrow or solid organ transplantation.
  • History of pneumonitis or active pneumonitis on chest CT.
  • Active hepatitis B or C infection as specified.
  • Active tuberculosis.
  • Uncontrolled tumor-related pain.
  • Recent live attenuated vaccine use or planned use during study.
  • Prior treatment with certain immune checkpoint therapies or systemic immunostimulants within defined periods.
  • Recent use of systemic corticosteroids or immunosuppressive medications beyond allowed exceptions.
  • Significant cardiovascular disease or clinically significant valvular defect.
  • History of other malignancies within 5 years except certain low-risk cancers.
  • Peripheral polyneuropathy grade 2 or higher.
  • Uncontrolled hypercalcemia.
  • Serious infection requiring antibiotics within 14 days.
  • Chronic inflammatory bowel disease or active gastrointestinal bleeding.
  • Major surgery within 4 weeks prior to treatment.
  • Other medical conditions contraindicating study medications or increasing risks.
  • Participation in other interventional studies within 30 days or concurrent participation.
  • Use of investigational drugs within 28 days.
  • Pregnant or breastfeeding females or those planning pregnancy within 6 months after treatment, with required negative pregnancy test prior to treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Klinikum St. Marien Kommunalunternehmen - Anstalt des öffentlichen Rechts der Stadt Amberg

Amberg, Germany

Actively Recruiting

2

HELIOS Klinikum Bad Saarow

Bad Saarow, Germany

Actively Recruiting

3

Charite Univeristätsmedizin Berlin

Berlin, Germany, 13353

Not Yet Recruiting

4

Universitätsklinikum Brandenburg an der Havel Medizinische Hochschule Brandenburg

Brandenburg an der Havel, Germany

Actively Recruiting

5

Krankenhaus St. Joseph-Stift GmbH

Bremen, Germany, 28209

Actively Recruiting

6

Klinikum Darmstadt GmbH

Darmstadt, Germany, 64283

Not Yet Recruiting

7

Kliniken Essen Mitte Klinik für Internistische Onkologie und Hämatologie

Essen, Germany

Actively Recruiting

8

Institute of Clinical Cancer Research, University Cancer Center (UCT) Frankfurt Krankenhaus Nordwest

Frankfurt, Germany

Actively Recruiting

9

Universitätsmedizin Göttingen

Göttingen, Germany, 37075

Actively Recruiting

10

Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin I

Halle, Germany

Actively Recruiting

11

Universitätsklinikum Heidelberg, RadioOnkologie & Strahlentherapie

Heidelberg, Germany

Actively Recruiting

12

St. Elisabeth Gruppe GmbH, St. Anna Hospital Herne

Herne, Germany

Actively Recruiting

13

Klinikverbund Allgäu gGmbH

Kempten, Germany, 87439

Actively Recruiting

14

Universitätsklinikum Schleswig-Holstein

Kiel, Germany, 24105

Not Yet Recruiting

15

ÜBAG - Medizinisches Versorgungszentrum Dr. Vehling-Kaiser GmbH

Landshut, Germany, 84036

Actively Recruiting

16

Klinikum Ludwigshafen gGmbH

Ludwigshafen, Germany, 67063

Actively Recruiting

17

Klinikum rechts der Isar der Technischen Universität München

München, Germany

Actively Recruiting

18

Gemeinschaftspraxis für Hämatologie und Onkologie GEHO

Münster, Germany

Actively Recruiting

19

Kreiskliniken Reutlingen GmbH Klinikum am Steinberg Reutlingen Ermstalklinik, Bad Urach

Reutlingen, Germany

Actively Recruiting

20

Leopoldina-Krankenhaus Medizinische Klinik II

Schweinfurt, Germany

Actively Recruiting

21

Klinikum Mutterhaus Trier

Trier, Germany

Actively Recruiting

22

Klinikum Wolfsburg

Wolfsburg, Germany

Actively Recruiting

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Research Team

T

Thorsten Götze, Prof. Dr.

CONTACT

U

Ulas Tenekeci, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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