Clinical Trials

Gastrointestinal Tumors

Recruitment stopped
Ongoing Recruitment

Pancreatic Carcinoma

ESPAC-5F

(neoadjuvant)
Title:EUROPEAN STUDY GROUP FOR PANCREATIC CANCER - TRIAL 5: Four arm, prospective, multicentre, randomised, feasibility trial of immediate surgery compared with neoadjuvant chemotherapies and neoadjuvant chemoradiotherapy
Indication:Pancreatic Adenocarcinoma
Type of study:Phase II
Contact: Birgit Erni (Study Nurse)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Thilo Hackert (Leiter klinische Prüfung)
Trial Register: Die Studie ist beim "ISRCTN - International Standard Randomised Controlled Trial Number Register" (Controlled-Trials.com) registriert. Siehe ISRCTN89500674 / NCT-2014-1230
EudraCT: 2013-003932-56 (siehe EU klinisches Studienregister)

HALO-109-301

(first-line)
Title:A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Indication:Adenocarcinoma
Type of study:Phase III
Contact: Stefanie Hofmann (Study Nurse)
[stefanie.hofmann@med.uni-heidelberg.de]
Investigator: Dr. med. Christoph Springfeld (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02715804
EudraCT: 2015-004068-13 (siehe EU klinisches Studienregister)

Quolixane

(first-line)
Title:Nicht-interventionelle Studie zur Erfassung der Lebensqualität, Wirksamkeit und Verträglichkeit bei Patienten mit metastasiertem Pankreaskarzinom unter Erstlinientherapie mit NabPaclitaxel und Gemcitabin.
Indication:Pancreatic cancer metastatic
Type of study:Phase IV
Investigator: Dr. med. Christoph Springfeld (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.

Noxxon Opera Studie (SNOXA12C601)

(second-line)
Title:A Two-Part, Open-Label Phase 1/2 Study to Evaluate Pharmacodynamic Effects and Safety of Olaptesed Pegol Monotherapy and Safety and Efficacy of Olaptesed Pegol / Pembrolizumab Combination Therapy in Metastatic Colorectal and Pancreatic Cancer
Indication:Colorectal cancer with liver metastases; Pancreatic cancer with liver metastases
Type of study:Phase I/II
Contact: Marlen Dettmer (Kontaktperson)
[Marlen.Dettmer@med.uni-heidelberg.de]
Investigator: Dr. med. Niels Halama (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-003657-15 (siehe EU klinisches Studienregister)

BMS-CA202-103

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: Sebastian Schülke (Kontaktperson)
[Sebastian.Schuelke@med.uni-heidelberg.de]
Investigator: PD Dr. med. 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)

ESPAC-4

Title:EUROPEAN STUDY GROUP FOR PANCREATIC CANCER –TRIAL 4. Combination versus single agent chemotherapy in resectable pancreatic cancer. A phase III, two arm, open-label, multi-centre randomised clinical trial comparing combination gemcitabine and capecitabine therapy with gemcitabine aloneA phase III, two arm, open-label, multi-centre randomised clinical trial comparing combination gemcitabine and capecitabine therapy with gemcitabine alone
Indication:complete macroscopic resection for peri-ampullary and ductal adenocarcinoma of the pancreas (R0 or R1 resection)
Type of study:Phase III
Contact: Andreas Schneider (Study Nurse)
[Andreas.Schneider@med.uni-heidelberg.de]
Investigator: Dr. med. Christin Tjaden (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT96397434
EudraCT: 2007-004299-38 (siehe EU klinisches Studienregister)

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 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.

Gastric and Oesophageal Carcinomas

OPTITREAT

(neoadjuvant, supportive care trial)
Title:Immediate tumor resection in patients with locally advanced gastroesophageal adenocarcinoma with nonresponse to chemotherapy after 4 weeks of treatment versus resection after completion of chemotherapy - A randomized controlled pilot trial
Indication:Patienten mit Ösophagus oder Magenkarzinom
Type of study:Phase N/A
Contact: Birgit Erni (Study Nurse)
[birgit.erni@med.uni-heidelberg.de]
Investigator: Dr. med. Susanne Blank (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.

PETRACA (FLOT-6)

(neoadjuvant)
Title:FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of Adenocarcinoma of the Stomach and Gastroesophageal Junction Expressing HER-2. A Phase II/III Trial of the AIO.
Indication:Stomach Neoplasms
Type of study:Phase II
Contact: Lisa Michel (Study Nurse)
[Lisa.Michel@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 NCT02581462
EudraCT: 2014-002695-86 (siehe EU klinisches Studienregister)

MATEO (AIO-YMO-0111)

(first-line)
Title:Randomized Controlled Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
Indication:Metastatic Esophagogastric Cancer (Adenocarcinoma)
Type of study:Phase II
Contact: Stefanie Hofmann (Study Nurse)
[stefanie.hofmann@med.uni-heidelberg.de]
Investigator: Dr. med. Martin Haag (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02128243
EudraCT: 2013-002742-37 (siehe EU klinisches Studienregister)

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:Adenocarcinoma Stomach Neoplasms
Type of study:Phase III
Contact: Lisa Michel (Study Nurse)
[Lisa.Michel@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 (Study Nurse)
[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.

Colorectal Carcinaomas (CRC)

Synchronous

(adjuvant)
Title:Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): a randomised controlled multicentre trial
Indication:Newly diagnosed, histologically confirmed colon cancer
Type of study:Phase IV
Contact: Dagmar Anders (Study Nurse)
[Dagmar.Anders@med.uni-heidelberg.de]
Investigator: Prof. Dr. Alexis Ulrich (Prüfer)
Trial Register: Die Studie ist beim "ISRCTN - International Standard Randomised Controlled Trial Number Register" (Controlled-Trials.com) registriert. Siehe ISRCTN30964555
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

MK-3475-177/KEYNOTE-177

(first-line)
Title:A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)
Indication:Carcinoma Colorectal Neoplasms Microsatellite Instability
Type of study:Phase III
Contact: Stefanie Hofmann (Study Nurse)
[stefanie.hofmann@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Dirk Jäger (Leiter klinische Prüfung)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02563002
EudraCT: 2015-002024-89 (siehe EU klinisches Studienregister)

Noxxon Opera Studie (SNOXA12C601)

(second-line)
Title:A Two-Part, Open-Label Phase 1/2 Study to Evaluate Pharmacodynamic Effects and Safety of Olaptesed Pegol Monotherapy and Safety and Efficacy of Olaptesed Pegol / Pembrolizumab Combination Therapy in Metastatic Colorectal and Pancreatic Cancer
Indication:Colorectal cancer with liver metastases; Pancreatic cancer with liver metastases
Type of study:Phase I/II
Contact: Marlen Dettmer (Kontaktperson)
[Marlen.Dettmer@med.uni-heidelberg.de]
Investigator: Dr. med. Niels Halama (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-003657-15 (siehe EU klinisches Studienregister)

PICCASSO

(second-line, metastatsiert, therapeutisch)
Title:A Phase I Trial of Combined PD-1 Inhibition (Pembrolizumab) and CCR5 Inhibition (Maraviroc) for the Treatment of Refractory Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)
Indication:Colorectal Neoplasms
Type of study:Phase I
Contact: Julia Weck (Study Nurse)
[julia.weck@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 NCT03274804
EudraCT: 2017-000193-11 (siehe EU klinisches Studienregister)

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 (Study Nurse)
[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.

DACHS

(epidemiologisch, Prävention)
Title:DACHS: Chancen der Verhütung durch Screening (potentials of prevention through screening)
Indication:GIT
Type of study:Phase N/A
Contact: Dr. Michael Hoffmeister (Kontaktperson)
[m.hoffmeister@dkfz-heidelberg.de]
Investigator: Dr. Michael Hoffmeister (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.

Blitz-Studie

(Prävention, diagnostisch, Früherkennung, Screening)
Title:Begleitende Evaluierung innovativer Testverfahren zur Darmkrebs-Früherkennung
Indication:colorectal cancer
Type of study:Phase N/A
Contact: Jason Hochhaus (Kontaktperson)
[j.hochhaus@dkfz-heidelberg.de]
Investigator: Prof. Dr. Hermann Brenner (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.

DARIO

(Prävention, diagnostisch, Früherkennung, Screening)
Title:Darmkrebsprävention – Innovative Wege am NCT
Indication:colorectal cancer
Type of study:Phase N/A
Contact: Prof. Dr. Hermann Brenner (Kontaktperson)
[h.brenner@dkfz-heidelberg.de]
Investigator: Dr Petra Schrotz-King (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-CA202-103

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: Sebastian Schülke (Kontaktperson)
[Sebastian.Schuelke@med.uni-heidelberg.de]
Investigator: PD Dr. med. 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)

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 III
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.

Vaccibody (VBN-01)

Title:An open labelled first human dose phase 1/2a study to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO immunotherapy in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of head and neck, who did not reach complete responses with current standard of care immune checkpoint blockade
Indication:Locally advanced or metastatic solid tumours including melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or SCCHN
Type of study:Phase I
Contact: Sebastian Schülke (Kontaktperson)
[Sebastian.Schuelke@med.uni-heidelberg.de]
Investigator: PD Dr. med. Jürgen Krauss (Leiter klinische Prüfung)
Trial Register: No trial registry number given.
EudraCT: 2017-002474-39 (siehe EU klinisches Studienregister)

Cholecystic and Gall Bladder Carcinomas

ACTICCA-1

(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:Cholangio carcinoma; Gallbladder Neoplasms
Type of study:Phase III
Contact: Margit Peters-Hornig (Study Nurse)
[margit.peters-hornig@med.uni-heidelberg.de]
Investigator: Dr. med. 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)

PCIA 202/12

(neoadjuvant)
Title:A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex-induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy in Patients with Locally Advanced Inoperable Cholangiocarcinomas
Indication:Locally Advanced Inoperable Cholangiocarcinoma (CCA)
Type of study:Phase I/II
Contact: Anette Manka-Stuhlik (Kontaktperson)
[anette.manka-stuhlik@med.uni-heidelberg.de]
Investigator: PD Dr. med. Jürgen Krauss (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01900158
EudraCT: 2012-002888-10 (siehe EU klinisches Studienregister)

ESPAC-4

Title:EUROPEAN STUDY GROUP FOR PANCREATIC CANCER –TRIAL 4. Combination versus single agent chemotherapy in resectable pancreatic cancer. A phase III, two arm, open-label, multi-centre randomised clinical trial comparing combination gemcitabine and capecitabine therapy with gemcitabine aloneA phase III, two arm, open-label, multi-centre randomised clinical trial comparing combination gemcitabine and capecitabine therapy with gemcitabine alone
Indication:complete macroscopic resection for peri-ampullary and ductal adenocarcinoma of the pancreas (R0 or R1 resection)
Type of study:Phase III
Contact: Andreas Schneider (Study Nurse)
[Andreas.Schneider@med.uni-heidelberg.de]
Investigator: Dr. med. Christin Tjaden (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT96397434
EudraCT: 2007-004299-38 (siehe EU klinisches Studienregister)

Hepatocellular Carcinomas

ACTICCA-1

(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:Cholangio carcinoma; Gallbladder Neoplasms
Type of study:Phase III
Contact: Margit Peters-Hornig (Study Nurse)
[margit.peters-hornig@med.uni-heidelberg.de]
Investigator: Dr. med. 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)

FGF401 (CFGF401X2101)

(second-line)
Title:A Phase I/II, Multicenter, Open-label Study of FGF401 in Adult Patients With Hepatocellular Carcinoma or Solid Malignancies Characterized by Positive FGFR4 and KLB ex<x>pression
Indication:Neoplasms
Type of study:Phase I/II
Contact: Lisa Michel (Study Nurse)
[Lisa.Michel@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 NCT02325739
EudraCT: 2014-002929-35 (siehe EU klinisches Studienregister)

MK-3475-240/KEYNOTE-240

(second-line)
Title:A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240)
Indication:Carcinoma, Hepatocellular
Type of study:Phase III
Contact: Cornelia Wurster (Study Nurse)
[cornelia.wurster@med.uni-heidelberg.de]
Investigator: Dr. med. Christoph Springfeld (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02702401
EudraCT: 2015-004567-36 (siehe EU klinisches Studienregister)

PriMalStHep

(chirurgisch)
Title:Randomisiert kontrollierte Studie zur Verwendung des Pringle Maneuvers zur Verringerung des Blutverlustes während der Stapler Leberresektion
Indication:Patienten mit Indikation zu Hemihepatektomie
Type of study:Phase N/A
Contact: Dagmar Anders (Kontaktperson)
[Dagmar.Anders@med.uni-heidelberg.de]
Investigator: Dr. med. Philipp Houben (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.

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: Prof. Dr. med. Jürgen Debus (Kontaktperson)
[juergen.debus@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

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: Ulla Wagner (Kontaktperson)
[Ulla.Wagner@med.uni-heidelberg.de]
Investigator: Dr. med. 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)