Clinical Trials

Gastrointestinal Tumors

Recruitment stopped
Ongoing Recruitment

Pancreatic Carcinoma

BMS-CA202-103 [Rekrutierung nach Anfrage]

Title:A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Indication:Colorectal Neoplasms, Pancreatic Neoplasms
Type of study:Phase I/II
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. Jürgen Krauss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03184870
EudraCT: 2017-001725-40 (siehe EU klinisches Studienregister)

Endo-POPF

Title:Endoscopic versus conservative management in the treatment of postoperative pancreatic fistula after distal pancreatectomy (Endo-POPF) – A randomized controlled pilot trial
Indication:Operation in der Behandlung bösartiger Tumoren, zystischer Läsionen oder bei chronischer Pankreatitis
Type of study:Phase N/A
Contact: Birgit Erni (Study Nurse)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Thilo Hackert (Prüfer)
Trial Register: Die Studie ist beim "DRKS - Deutsches Register Klinischer Studien" registriert. Siehe DRKS00015765
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Heparflow

Title:Intraoperative Evaluation of the Hepatic Artery Blood Flow during Pancreatoduodenectomy
Indication:Patienten bei denen eine partielle oder totale Pankreatoduodenectomie durchgeführt wird
Type of study:Phase N/A
Contact: Leonie Frank-Moldzio (Kontaktperson)
[Leonie.Frank-Moldzio@med.uni-heidelberg.de]
Investigator: Prof. Dr. Oliver Strobel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Luminescence [Rekrutierung nach Anfrage]

Title:Ipilimumab, Maraviroc and Nivolumab in advanced metastatic colorectal and pancreatic cancer (ipiLimUmab, MaravIroc and Nivolumab in mEtaStatic ColorEctal and paNcreatic CancEr):the LUMINESCENCE trial
Indication:Colorektales Carcinom, Pankreaskarzinom
Type of study:Phase I
Contact: Anette Manka-Stuhlik (Study Nurse)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: PD Dr. Niels Halama (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

META-PAC

Title:Prospektive Studie zum Plasma-Metabolom Multimarker Panel MxP®PancreasScore zum Ausschluss eines Pankreaskarzinoms in Risikokohorten
Indication:Pankreaskarzinoms
Type of study:Phase N/A
Contact: Birgit Erni (Kontaktperson)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Prof. Dr. Oliver Strobel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

NCT-PMO-1603 TOP-ART

Title:A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies
Indication:Krebs mit DNA-Reparatur-Defizite
Type of study:Phase II
Contact: Barbara Stöhr (Study Nurse)
[barbara.stoehr@nct-heidelberg.de]
Investigator: Prof. Dr. Stefan Fröhling (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03127215
EudraCT: 2017-001755-31 (siehe EU klinisches Studienregister)

PANDRA II

Title:Vergleich zwischen abdomineller Drainageneinlage mit keiner Drainageneinlage nach offener oder laparoskopischer Pankreaslinksresektion
Indication:Patienten mit malignen und benignen Erkrankungen des Pankreaskorpus oder Pankreasschwanzes, die für eine Pankreaslinksresektion geplant sind
Type of study:Phase N/A
Contact: Birgit Erni (Study Nurse)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Thilo Hackert (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

PROSPER

Title:Randomisierte, doppelt verblindete, Placebo kontrollierte, Phase II – Studie zum Off-Label Einsatz von Etodolac und Propranolol im perioperativen Setting von Pankreasoperationen
Indication:Pankreaskarzinom
Type of study:Phase II
Contact: Birgit Erni (Study Nurse)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Markus Diener (Prüfer)
Trial Register: Die Studie ist beim "DRKS - Deutsches Register Klinischer Studien" registriert. Siehe DRKS00014054
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

PancER

Title:Conventional partial pancreatoduodenectomy versus an uncinate first, extended partial pancreatoduodenectomy approach for the resection of pancreatic head ductal adenocarcinoma (PancER)
Indication:Suspected pancreatic ductal adenocarcinoma of the pancreatic head
Type of study:Phase N/A
Contact: Birgit Erni (Study Nurse)
[birgit.erni@med.uni-heidelberg.de]
Investigator: PD Dr. med André Mihalejevic (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Gastric and Oesophageal Carcinomas

Renaissance (FLOT5)

(first-line)
Title:Effect of Chemotherapy Alone vs. Chemotherapy Followed by Surgical Resection on Survival and Quality of Life in Patients With Limited-metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction - A Phase III Trial of Arbeitsgemeinschaft Internistische Onkologie/Chirurgische Arbeitsgemeinschaft Onkologie/Chirurgische Arbeitsgemeinschaft für Den Oberen Gastrointestinaltrakt (AIO/CAO-V/CAOGI)
Indication:Adenokarzinom Ösophagus/Magen
Type of study:Phase III
Contact: Stefanie Hofmann (Study Nurse)
[stefanie.hofmann@med.uni-heidelberg.de]
Investigator: Dr. med. Martin Haag (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02578368
EudraCT: 2014-002665-30 (siehe EU klinisches Studienregister)

OPPOSITE

(Biomarker)
Title:Molecular Outcome Prediction of Neoadjuvant Systemic Treatment in Esophagogastric Carcinoma
Indication:Bösartige Neubildung des Ösophagus, Bösartige Neubildung des Magens
Type of study:Phase N/A
Contact: Dr. med. Martin Haag (Kontaktperson)
[GeorgMartin.Haag@med.uni-heidelberg.de]
Investigator: Dr. med. Martin Haag (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03429816
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

BioNTech –Forschungsstudie (RB_T002)

(diagnostisch, Früherkennung, Screening)
Title:Identifikation von individuellen Krebsmutationen und Testung ihrer Immunogenität
Indication:-
Type of study:Phase N/A
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Dirk Jäger (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

BMS CA224-060

Title:A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (anti-LAG-3) plus Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-Line Treatment in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma
Indication:Metastasiertes Magenkarzinom / Adenokarzinome des ösophagogastralen Übergangs
Type of study:Phase II
Contact: Mirjam Campbell (Study Nurse)
[Mirjam.Campbell@med.uni-heidelberg.de]
Investigator: Dr. med. Martin Haag (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03662659
EudraCT: 2018-001069-18 (siehe EU klinisches Studienregister)

DANTE/FLOT8

Title:A randomized, open-label Phase II efficacy and safety study of Atezolizumab in combination with FLOT versus FLOT alone in patients with gastric cancer and adenocarcinoma of the oesophago-gastric junction (MO30039) – The DANTE Trial
Indication:Lokal fortgeschrittener resektabler Magenkrebs
Type of study:Phase II
Contact: Mirjam Campbell (Study Nurse)
[Mirjam.Campbell@med.uni-heidelberg.de]
Investigator: Dr. med. Martin Haag (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03421288
EudraCT: 2017-001979-23 (siehe EU klinisches Studienregister)

NCT-PMO-1603 TOP-ART

Title:A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies
Indication:Krebs mit DNA-Reparatur-Defizite
Type of study:Phase II
Contact: Barbara Stöhr (Study Nurse)
[barbara.stoehr@nct-heidelberg.de]
Investigator: Prof. Dr. Stefan Fröhling (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03127215
EudraCT: 2017-001755-31 (siehe EU klinisches Studienregister)

Colorectal Carcinaomas (CRC)

GHOST

(chirurgisch)
Title:Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer
Indication:Resektion bei Rektumkarzinom
Type of study:Phase N/A
Contact: Birgit Erni (Study Nurse)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Markus Diener (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

BioNTech –Forschungsstudie (RB_T002)

(diagnostisch, Früherkennung, Screening)
Title:Identifikation von individuellen Krebsmutationen und Testung ihrer Immunogenität
Indication:-
Type of study:Phase N/A
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Dirk Jäger (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

ColoCare Studie

(epidemiologisch)
Title:“Transdisciplinary Research in Colon Cancer Prognosis.” Prospektive Kohortenstudie
Indication:Kolorektales Karzinom, Stadium I - IV
Type of study:Phase N/A
Contact: Birgit Erni (Kontaktperson)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Prof. Dr. Alexis Ulrich (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02391597
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

BMS-CA202-103 [Rekrutierung nach Anfrage]

Title:A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Indication:Colorectal Neoplasms, Pancreatic Neoplasms
Type of study:Phase I/II
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. Jürgen Krauss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03184870
EudraCT: 2017-001725-40 (siehe EU klinisches Studienregister)

Luminescence [Rekrutierung nach Anfrage]

Title:Ipilimumab, Maraviroc and Nivolumab in advanced metastatic colorectal and pancreatic cancer (ipiLimUmab, MaravIroc and Nivolumab in mEtaStatic ColorEctal and paNcreatic CancEr):the LUMINESCENCE trial
Indication:Colorektales Carcinom, Pankreaskarzinom
Type of study:Phase I
Contact: Anette Manka-Stuhlik (Study Nurse)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: PD Dr. Niels Halama (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

NCT-PMO-1603 TOP-ART

Title:A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies
Indication:Krebs mit DNA-Reparatur-Defizite
Type of study:Phase II
Contact: Barbara Stöhr (Study Nurse)
[barbara.stoehr@nct-heidelberg.de]
Investigator: Prof. Dr. Stefan Fröhling (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03127215
EudraCT: 2017-001755-31 (siehe EU klinisches Studienregister)

ReLap Study

Title:Relaparotomie Studie - Prospektive Studie zum Versorgungsstandard und Outcome von relaparotomierten Patienten mit einem randomisierten Schritt (Faszienverschluss)
Indication:Abdominelle Re-Operationen Primäre Laparotomie
Type of study:Phase N/A
Investigator: Pascal Probst (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

STARTRK-2/ RXDX-101-92

Title:AN OPEN-LABEL, MULTICENTER, GLOBAL PHASE 2 BASKET STUDY OF ENTRECTINIB FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS THAT HARBOR NTRK1/2/3, ROS1, OR ALK GENE REARRANGEMENTS
Indication:Lokal fortgeschrittene oder metastatische solide Tumore
Type of study:Phase II
Contact: Stefanie Hofmann (Study Nurse)
[stefanie.hofmann@med.uni-heidelberg.de]
Investigator: Prof. Dr. Christoph Springfeld (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2015-003385-84 (siehe EU klinisches Studienregister)

Cholecystic and Gall Bladder Carcinomas

ACTICCA-1 [on hold]

(adjuvant)
Title:Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)
Indication:Gallengangskarzinom/ Gallenblasenkarzinom
Type of study:Phase III
Contact: Margit Peters-Hornig (Study Nurse)
[margit.peters-hornig@med.uni-heidelberg.de]
Investigator: Prof. Dr. Christoph Springfeld (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02170090
EudraCT: 2012-005078-70 (siehe EU klinisches Studienregister)

CBGJ398X2204

(second-line)
Title:A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy
Indication:Gallengangskarzinom
Type of study:Phase II
Contact: Ulrike Lauterbach (Study Nurse)
[Ulrike.Lauterbach@med.uni-heidelberg.de]
Investigator: PD Dr. med. Karl-Heinz Weiss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02150967
EudraCT: 2013-005085-19 (siehe EU klinisches Studienregister)

IMMUCHEC

Title:A Randomized Phase II Trial of Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine and Cisplatin Compared to Gemcitabine and Cisplatin in Treatment-naïve Patients With Cholangio- and Gallbladder Carcinoma (IMMUCHEC)
Indication:Patienten mit Gallengangskarzinom, die bisher keine Chemo- oder Immuntherapie bekommen haben.
Type of study:Phase II
Contact: Stefanie Hofmann (Study Nurse)
[stefanie.hofmann@med.uni-heidelberg.de]
Investigator: Prof. Dr. Christoph Springfeld (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03473574
EudraCT: 2017-001538-25 (siehe EU klinisches Studienregister)

Hepatocellular Carcinomas

PROMETHEUS-01

(Schwerionentherapie, radiologisch)
Title:Phase I study evaluating the treatment of patients with hepatocellular carcinoma (HCC) with Carbon Ion Radiotherapy
Indication:Hepatozelluläres Karzinom
Type of study:Phase I
Contact: Dr. med. Matthias Häfner (Kontaktperson)
[matthias.haefner@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Jürgen Debus (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01167374
EudraCT: 2010-018328-23 (siehe EU klinisches Studienregister)

CIN Novartis [Rekrutierung nach Anfrage]

Title:A Phase Ib/II, Open-label, Multi-center Study of INC280 in Combination With PDR001 or PDR001 Single Agent in Advanced Hepatocellular Carcinoma.
Indication:CarcinomaCarcinoma, Hepatocellular
Type of study:Phase I/II
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. Christoph Springfeld (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02795429
EudraCT: 2015-005417-76 (siehe EU klinisches Studienregister)