Current active studies
Principal Investigators:
PD Dr. Anna Saborowski - Saborowski.Anna@mh-hannover.de
PD Dr. Thomas Wirth - Wirth.Thomas@mh-hannover.de
Hepatocellular carcinoma | Esophageal cancer/AEG/Stomach | Colorectal carcinoma | Bile duct or cholangiocarcinoma | Neuroendocrine neoplasms (NEN) | Pancreatic carcinoma | Solid tumors | |
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| Syst. 1st line | ARTEMIDE | HLX22-GC-301 LUCERNA (8951-CL-0305) | S095031-210 JZP598-302 |
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| Syst. 2nd-line | GDFATHER-HCC-01 |
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Local
IMMUWIN
A phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with either Y-90
SIRT or TACE for intermediate stage HCC with pick-the-winner design
ABC-HCC
A Phase IIIb, randomized, multicenter, open-label trial of Atezolizumab plus Bevacizumab versus trans arterial Chemoembolization (TACE) in intermediate-stage
HCC
First-line therapy
ARTEMIDE
A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line
Treatment in Patients with advanced Hepatocellular Carcinoma
Second-line therapy
GDFATHER-HCC-01 (CTL-002-005)
A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in combination with Nivolumab and Lenvatinib compared to
Double Placebo and Lenvatinib in Participants with Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function
(Child-Pugh A) after Failure of First-Line Treatment that Included an Anti-PD-(L)1 Compound (GDFATHER-HCC-01)
First-line therapy
HLX-GC-301
A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy (XELOX) versus Trastuzumab and Chemotherapy (XELOX) with or without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer
LUCERNA (8951-CL-0305)
A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive. A Study of Zolbetuximab together with Pembrolizumab and Chemotherapy in Adults with Gastric Cancer LUCERNA ISN/Protocol 8951-CL-0305.
Adjuvant
FIRE-9 / PORT
Prospective, randomized, open-multicenter Phase III to investigate the efficacy of active post-resection/ablation therapy in patients with metastatic colorectal cancer, R0/R1 reseziert
First-line therapy
MOUNTAINEER-03 (SGNTUC-029)
An open label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-Line Treatment for Subjects with HER2+ Metastatic Colorectal cancer
Second-line therapy
QUINTIS (AIO-KRK-0324)
A Randomized Phase II Trial Evaluating Fruquintinib in Combination with Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR)
Metastatic Colorectal Cancer without Active Liver Metastases
Third-line therapy
PHP-CRC-201
An open-label randomized, multicenter study to evaluate the efficacy and safety of induction treatment with melphalan/HDS.Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab versus Trifluridine-tipiracil plus Bevacizumab alone in Patients with Refractory Metastatic Colorectal Cancer with Liver-Dominant Disease
Local
Clean-Duct/ TRITICC-3
Phase IIa, prospective, single-arm, open-label, non-randomized, multicenter pilot study of durvalumab (MEDI4736) + intraductal radiofrequency ablation (ID-RFA) in extrahepatic cholangiocarcinoma
Acticca-2
Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial) . A randomized, open-label investigator-initiated trial
First-line therapy
S095031-210
A Phase 1b/2, Safety Lead-in and Dose-Expansion, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Activity of Ivosidenib in Combination with Durvalumab and Gemcitabine/Cisplatin as First-line Therapy in Participants with Locally Advanced, Unresectable, or Metastatic Cholangiocarcinoma with an IDH1 Mutation
JZP598-302
An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy versus standard-of-care therapy alone for advanced HER2-positive biliary tract cancer