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Clinical Trials

Group of GI tract diseases

  • Phase III Study (ATTRACTION-6 Study): A multicenter, cooperative research study investigating the efficacy and safety of ONO-4538, ipilimumab, and chemotherapy in subjects with HER2-negative, unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) who have not received chemotherapy.
  • Phase III Randomized Trial (STAR221 Study): A multicenter, cooperative research study comparing the combination of Domvanalimab, Zimberelimab, and chemotherapy with the combination of nivolumab and chemotherapy in adult patients with advanced upper gastrointestinal adenocarcinoma.
  • Phase II Study: A multicenter, cooperative research study evaluating the efficacy of nab-paclitaxel, ramucirumab, and nivolumab in patients with unresectable advanced or recurrent gastric cancer who are refractory to first-line treatment with fluoropyrimidine, platinum agents, and anti-PD-1/PD-L1 antibodies.
  • Phase I/II Study: A multicenter, cooperative research study assessing the safety and efficacy of S-1, including optimal dosing based on the BBT method, combined with oxaliplatin and nivolumab for HER2-negative, unresectable, advanced or recurrent gastric cancer.
  • Phase II Study: A multicenter, cooperative research study evaluating the safety and efficacy of panitumumab combined with irinotecan in patients with RAS wild-type, unresectable advanced or recurrent colorectal cancer.
  • Phase III Randomized Trial: A multicenter, cooperative research study comparing the conventional and biweekly administration methods of trifluridine/tipiracil plus bevacizumab in patients with unresectable colorectal cancer.
  • Patient Requested Therapy (BELIEVE): A multicenter, cooperative research study involving gene panel testing for gene profiling and its application to multiple molecular targeted therapies.

Group of Biliary and Pancreatic diseases

  • Phase II Open-Label Randomized Trial: Evaluates the antitumor activity and safety of Zolbetuximab (IMAB362) in combination with Nab-paclitaxel and gemcitabine (Nab-P + GEM) as first-line treatment for metastatic pancreatic adenocarcinoma with positive Claudin 18.2 (CLDN18.2) expression.
  • Phase I Study (ONO-7913): An open-label, non-comparative trial assessing the combination of ONO-7913 and ONO-4538 with standard modified FOLFIRINOX therapy as first-line treatment in patients with metastatic pancreatic cancer.
  • Phase I Study (ONO-4578): An open-label, non-comparative trial evaluating the combination of ONO-4578 and ONO-4538 with either standard modified FOLFIRINOX (mFFX) therapy or gemcitabine and nab-paclitaxel (GnP) therapy as first-line treatment in patients with metastatic pancreatic cancer.
  • Phase II Multicenter, Open-Label Trial: Assesses the efficacy of E7090 in patients with unresectable or metastatic cholangiocarcinoma with FGFR2 fusion genes.
  • Phase III Open-Label, Randomized Trial: Compares the efficacy and safety of Pemigatinib as first-line treatment with gemcitabine plus cisplatin chemotherapy in patients with unresectable or metastatic cholangiocarcinoma with FGFR2 gene rearrangement.
  • Phase I/II Study: Evaluates the combination of gemcitabine/nab-paclitaxel intravenous infusion with intraperitoneal paclitaxel administration as treatment for pancreatic cancer with peritoneal dissemination.

Group of Liver diseases

  • Phase IIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial: Evaluates the efficacy, safety, and tolerability of AZD2693 in patients with non-alcoholic steatohepatitis (NASH) with fibrosis who carry the PNPLA3 rs738409 148M risk allele.