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)

Clarinet forte (8-79-52030-326)

(second-line)
Title:Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days
Indication:Apudoma Carcinoid Tumor Neoplasms Neuroendocrine Tumors Pancreatic Neoplasms
Type of study:Phase II
Contact: Julia Weck (Study Nurse)
[julia.weck@med.uni-heidelberg.de]
Investigator: Dr. med. Leonidas Apostolidis (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02651987
EudraCT: 2014-005607-24 (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)

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)

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: 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 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 (Prüfer)
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)

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.

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)

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)

HEP-0117/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:CarcinomaCholangiocarcinomaUrinary Bladder NeoplasmsGallbladder Neoplasms
Type of study:Phase II
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 NCT03473574
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

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)

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:Cholangiocarcinoma
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)

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: 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 NCT02325739
EudraCT: 2014-002929-35 (siehe EU klinisches Studienregister)

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. Stefan Körber (Kontaktperson)
[Stefan.Koerber@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: Nadine Heydrich (Study Nurse)
[Nadine.Heydrich@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)

HIMALAYA

Title:A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Indication:CarcinomaCarcinoma, Hepatocellular
Type of study:Phase III
Investigator: Margit Peters-Hornig (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03298451
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

PHOCUS

Title:A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy
Indication:CarcinomaCarcinoma, Hepatocellular Vaccinia
Type of study:Phase III
Contact: Stefanie Hofmann (Kontaktperson)
[stefanie.hofmann@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 NCT02562755
EudraCT: 2014-001985-86 (siehe EU klinisches Studienregister)