Cholangiocarcinoma News

25 US-Based Clinical Trials of Note in CCA

March 2023, Vol 4, No 1

That Are Active and Recruiting

Systemic Medical Therapy/Phase 2-3

Clinical trial recruitment and retention remain challenging in the quest to bring innovative medicines to patients. In oncology, therapies continue to evolve, yet researchers are frequently faced with low trial participation, particularly among minority groups.

This new CCA News feature aims to provide an ongoing list of US-based clinical trials that are actively recruiting for clinicians to use in discussions with their patients to encourage enrollment. The highlighted trials are new to this issue. Clinical trial identifiers can be found on

    New Trials in this Issue

  • XmAb20717 in Advanced Biliary Tract Cancers: NCT05297903
  • Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC): NCT04057365
  • Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer: NCT03482102
  • NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer: NCT04005339
  • Olaparib in Treating Patients with Metastatic Biliary Tract Cancer with Aberrant DNA Repair Gene Mutations: NCT04042831
  • A Study of CTX-009 in Combination with Paclitaxel in Adult Patients with Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers: NCT05506943
  • A Study to Determine Whether Chemotherapy, Bevacizumab, and Atezolizumab Is Better Than Chemotherapy Alone in Patients with Advanced Liver Cancer: NCT05211323
  • Durvalumab and Tremelimumab with Platinum-Based Chemotherapy in Intrahepatic Cholangiocarcinoma: NCT04989218
  • A Study to Evaluate the Efficacy and Safety of Pemigatinib versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma (FIGHT-302): NCT03656536
  • Gemcitabine and Cisplatin with Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma: NCT04088188
  • Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma: NCT04919642
  • Pressure-Enabled Delivery of SD-101 with Checkpoint Blockade for Primary Liver Tumors: NCT05220722
  • Olaparib in Treating Patients with Advanced Glioma, Cholangiocarcinoma, or Solid Tumors with IDH1 or IDH2 Mutations: NCT03212274
  • REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with ICC and Other Advanced Solid Tumors: NCT04526106
  • Study of LY3410738 Administered to Patients with Advanced Solid Tumors with IDH1 or IDH2 Mutations: NCT04521686
  • Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors: NCT03878095
  • Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors: NCT03991832
  • Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC): NCT04566133
  • LYT-200 Alone and in Combination with Chemotherapy or Anti-PD-1 in Patients with Metastatic Solid Tumors: NCT04666688
  • A Study to Evaluate KIN-3248 in Participants with Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations: NCT05242822
  • Gemcitabine and Cisplatin with or without CPI-613 as First Line Therapy for Patients with Advanced Unresectable Biliary Tract Cancer (BilT-04): NCT04203160
  • Testing a New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) with or without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer: NCT04941287
  • Atezolizumab plus Tivozanib in Immunologically Cold Tumor Types: NCT05000294
  • Study of TT-00420 Tablet as Monotherapy and Combination Therapy in Patients with Advanced Solid Tumors: NCT04742959
  • A Safety and Efficacy Study of ZW25 (Zanidatamab) plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer: NCT03929666

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